GSK Clinical Study Register

In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clinical Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 AN OPEN LABEL, 12 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE MAXCLARITY SYSTEM (BENZOYL PEROXIDE 2.5%, SALICYLIC ACID 0.5%) IN SUBJECTS WITH ACNE CLINICAL STUDY REPORT U0289-405 VERSION 1.0 22 May 2012 Sponsored by: Stiefel, a GSK company 20 TW Alexander Drive Research Triangle Park North Carolina, 27709 Conducted by: Stiefel, a GSK company 20 TW Alexander Drive Research Triangle Park North Carolina, 27709 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR STIEFEL OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF STIEFEL. STIEFEL CONFIDENTIAL Page 1

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 1 TITLE PAGE An Open Label, 12 Week Study to Evaluate the Efficacy and Safety of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne Name of Investigational Product Indication Description MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA). Acne Open Label, 12-week efficacy and safety evaluation of the MaxClarity System in facial acne. Stiefel, a GSK company Sponsor Protocol/Study Number U0289-405 Development Phase Consumer Health Non-Prescription Post-Launch Study Study Initiation Date 23 June 2011 Study Completion Date 14 December 2011 Sponsor s Responsible MD Medical Officer Consultant Stiefel, a GSK company Responsible Signatory MD Consultant Stiefel, a GSK company Date of the report 22 May 2012 This study was performed in accordance with Good Clinical Practices, including guidelines outlined by the International Conference on Harmonisation. STIEFEL CONFIDENTIAL Page 2

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 2 SYNOPSIS NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) Title of study: An Open Label, 12 Week Study to Evaluate the Efficacy and Safety of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne. Investigators: MD MD MD MD MD MD MD MD MD Publication (reference): No publications related to this study were published as of the date of this report. Study initiation/completion dates: The first subject was enrolled on 23 June 2011 and the last subject completed on 14 December 2011. Phase of Development: n/a Objectives: The primary objective was to assess the efficacy of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes MaxClarity Foam Deep Cleanser (2.5% BPO) and MaxClarity Foam Advanced Acne Treatment (2.5% BPO) and MaxClarity Foam Rejuvenating Toner (0.5% SA), in the treatment of moderate to severe acne. The secondary objective was to evaluate the safety and subject satisfaction of this treatment regimen. Methodology: This was a multi-center, open label, safety and efficacy study. One-hundred twenty (120) male/female subjects, 12 to 35 years of age, were to be enrolled into this study. The study duration is 12 weeks (84 days) with study visits occurring at baseline (day 1), week 1, week 2, week 4, week 8, and week 12. Number of subjects (planned and analyzed): 120 subjects planned; 125 enrolled and applied study medication. 115 subjects completed the study and 10 subject discontinued participation prematurely. Diagnosis and Main Criteria for Inclusion: - Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed. - Male or female ages 12 to 35 years, inclusive, at time of consent. - Investigator s Static Global Assessment (ISGA) score of 3 or 4 at Baseline. - Lesion counts meeting all of the following criteria: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. A minimum of 20 but not more than 100 facial noninflammatory lesions (open and closed comedones) on the face, excluding nasal lesions. No more than 3 facial nodular lesions (<5 mm), with no cystic lesions. STIEFEL CONFIDENTIAL Page 3

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) - Able and willing to follow all study procedures, attend all visits, and successfully complete the study. - Female subjects of childbearing potential (CBP) required a negative pregnancy test. Sexually active women of CBP participating in the study must have been using a medically acceptable method of contraception. Duration of Study: 12 weeks. Test Product, Dose and Mode of Administration, Batch No.: Max Clarity Foam Deep Cleanser (2.5% BPO; Lot D0J567). Max Clarity Foam Advanced Acne Treatment (2.5% BPO; Lot D0J589). Max Clarity Foam Rejuvenating Toner (0.5% SA; Lot D0J571). AM regimen (wash face with Foam Deep Cleanser, pat dry, apply thin layer of Foam Advanced Acne Treatment); PM regimen (wash face with Foam Deep Cleanser, pat dry, apply Foam Rejuvenating Toner). Criteria for Evaluation: Efficacy: Primary endpoints: - Mean percent change from baseline in inflammatory, non-inflammatory and total lesion counts at each study visit. - Proportion of subjects with a minimum 2-grade improvement in ISGA from Baseline to each study visit. - Proportion of subjects with an ISGA score of 0 (clear) or 1 (almost clear) at each study visit. Secondary endpoints: - Absolute change in inflammatory, non-inflammatory and total lesion counts from Baseline to each study visit. - Mean change in ISGA from Baseline to each study visit. - Post-Inflammatory Hyper pigmentation (Overall Severity) at each study visit. - Post-Inflammatory Hyper pigmentation (Distribution of PIH; % of face affected) at each study visit. - Subject Global Improvement Scale. Patient Preference: - Subject Preference Post-Study Questionnaire. Safety: - Adverse Event reporting. - Concomitant medication use. Statistical Methods: All statistical analyses were performed on the intent-to-treat (ITT) analysis set using SAS software (version 9.2). The ITT analysis set included data from all subjects that were enrolled into the study. A formal sample size calculation was not conducted. No formal statistical hypothesis was formulated for this study. Data are presented in a descriptive fashion and as reported in the case report form (CRF). No inferential statistical testing was conducted and no estimation of missing data was performed. No particular processing for outliers was performed. Descriptive statistics are used to provide an overview of the efficacy and tolerability and safety results. For categorical parameters, the number and percentage of subjects in each category are presented. The denominator for percentage is based on the number of subjects appropriate for the purpose of analysis. For continuous parameters, descriptive statistics include n (number of subjects), mean, standard deviation (STD), median, and range. No estimation of missing data was performed. Age is calculated in years (1 year = 365.25 days) from birth date to the first dose date and presented with one decimal. No particular STIEFEL CONFIDENTIAL Page 4

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable processing for outliers was performed. Data is presented as reported in the CRF. (FOR NATIONAL AUTHORITY USE ONLY) For the final analysis, Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA, Version 14.1) by system organ class (SOC) and preferred term. Tables summarizing subject incidence of all AEs, serious AEs, severe AEs, treatment-related AEs, treatment-related serious AEs, and treatment-related severe AEs will be provided. All summaries will include treatment emergent events only. Also for the final analysis, prior and concomitant medications will be coded according to the World Health Organization Drug Dictionary (WHODrug) January 2009. Individual subject listings of all data represented on the CRF were produced, but are not included with this report. In general, one listing was produced per CRF domain which was sorted by subject number. Additional listings were prepared to support selected summary tables. Individual subject listings will be provided upon request. SUMMARY CONCLUSIONS Efficacy Results: Primary analyses: Lesion counts: At week 12, clinically significant reductions in all lesion types were seen. Mean ± SD percent reduction from baseline of -61.6 ± 22.0% in total lesions was noted. Inflammatory lesions appeared more responsive than noninflammatory lesions to study product. At week 12, reductions from baseline in inflammatory and noninflammatory lesions were -67.1 ± 22.7% and -57.3 ± 25.8%, respectively. At weeks 1, 2, 4 and 8, clinically significant reductions from baseline were noted with all lesion outcomes (see Table 1 below and Section 5.2.2, Summary Tables 5.1, 5.2 and 5.3). Table 1. Summary of Primary Efficacy Results Lesion Counts Primary Efficacy Outcomes Mean percent change in inflammatory lesion count from baseline to: Mean percent change in noninflammatory lesion count from baseline to: Mean percent change in total lesion count from baseline to: Source: Summary Tables 5.1, 5.2, 5.3, Section 5.2.2. MaxClarity II (mean ± SD) week 1-30.4 ± 25.8% week 2-44.8 ± 26.4% week 4-52.9 ± 27.0% week 8-59.8 ± 23.7 week 12-67.1 ± 22.7 week 1-14.8 ± 24.4% week 2-28.5 ± 24.4% week 4-37.1 ± 30.1% week 8-43.8 ± 29.3 week 12-57.3 ± 25.8 week 1-22.2 ± 20.6% week 2-36.0 ± 21.5% week 4-44.4 ± 23.6% week 8-51.0 ± 23.2 week 12-61.6 ± 22.0 STIEFEL CONFIDENTIAL Page 5

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) At week 12, the proportion of subjects achieving minimal 2-grade improvement in the ISGA was 25.4% (31/122 subjects) and the proportion of subjects with an IGSA score of 0 (clear) or 1 (almost clear) was 16.4% (20/122 subjects). Improvement in IGSA increased steadily throughout the study (see Table 2 below and Section 5.2.2, Summary Table 6). Table 2. Summary of Primary Efficacy Results ISGA Primary Efficacy Outcomes Proportion of subjects with a >2-grade improvement from Baseline to: Proportion of subjects with a score of 0 (clear) or 1 (almost clear): Source: Summary Table 6, Section 5.2.2. MaxClarity II n (%) week 1 3 (2.5%) week 2 6 (5.0%) week 4 12 (10.0%) week 8 19 (16.4%) week 12 31 (25.4%) week 1 1 (0.8%) week 2 2 (1.7%) week 4 4 (3.3%) week 8 10 (8.6%) week 12 20 (16.4%) Secondary analyses: Absolute change in lesion counts: At week 12, the mean ± SD change in inflammatory lesions from baseline was -21.4 ± 8.2 lesions. The mean change in non-inflammatory lesions from baseline was -25.6 ± 15.3 at week 12. The mean change in total lesions from baseline was -47.0 ± 19.8 at week 12. At weeks 1, 2, 4 and 8, clinically significant reductions from baseline were noted with all lesion outcomes (see Section 5.2.2, Summary Table 5.1, 5.2 and 5.3). Mean change in ISGA: The mean ± SD change in ISGA from baseline was -1.05 ± 0.78 at week 12 with steady improvement in IGSA being noted throughout the study (see Section 5.2.2, Summary Table 6). Mean change in Post-Inflammatory Hyperpigmentation: The mean ± SD change from baseline in PIH Overall Severity was -0.29 ± 0.58 at week 12 (see Section 5.2.2, Summary Table 7.1). The mean change from baseline in PIH Distribution was -0.21 ± 0.53 at week 12. Reductions in PIH Overall Severity and PIH Distribution were noted throughout the study (see Section 5.2.2, Summary Table 7.2). Subject Global Improvement Scale: The mean ± SD change from baseline in Subject Global Improvement was 2.57 ± 0.98 at week 12 with 85.6% of subjects noting at least mild improvement (see Section 5.2.2, Summary Table 8). Patient Preference Results: In measurements of Subject Preference, 70.5% of subjects indicated that they Agree or Strongly Agree when asked if they were Satisfied with Study Products. Compared to Acne Products Used in Past, 66.9% of subjects indicated that they liked the MaxClarity System the best. Please see Section 5.2.3 for the full set of patient preference results. STIEFEL CONFIDENTIAL Page 6

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) Safety Results: No treatment-related AE were reported with the used of the study products. One subject was withdrawn from study participation due to the occurrence of non-treatment related adverse events (rash on face). There were no SAEs. Please see Section 5.2.4, for the full set of safety results. Conclusions: Clinically significant reductions in all acne lesion counts at all study visits with the MaxClarity System. MaxClarity was also well tolerated with no treatment-related AEs or SAEs reported. Date of the report: 22 May 2012 Signature: Date: MD Contractor Stiefel, a GSK company STIEFEL CONFIDENTIAL Page 7

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 3 TABLE OF CONTENTS 1 TITLE PAGE... 2 2 SYNOPSIS... 3 3 TABLE OF CONTENTS... 8 4 REFERENCE LIST... 9 5 APPENDICES... 10 5.1 Safety Evaluation... 10 5.1.1 Extent of Exposure... 10 5.1.2 Adverse Events... 10 5.1.2.1 Brief Summary of Adverse Events... 10 5.1.2.2 Display of Adverse Events... 10 5.1.2.3 Analysis of Adverse Events... 12 5.1.2.4 Listing of Adverse Events by Subject... 12 5.1.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events... 12 5.1.3.1 Listing of Deaths, Other SAEs, and Other Significant AEs... 12 5.1.3.2 Narratives of Deaths, Other SAEs, and Certain Other Significant AEs... 12 5.1.3.3 Analysis and Discussion of Deaths, Other SAEs, and Other Significant AEs.. 12 5.1.4 Clinical Laboratory Evaluation... 12 5.1.5 Vital Signs, Physical Findings, and Other Observations Related to Safety... 12 5.1.6 Safety Conclusions... 12 5.2 Tables, Figures and Graphs Referred to but not Included in the Text... 13 5.2.1 Subject Disposition and Demographic Data... 13 5.2.2 Efficacy Data... 18 5.2.3 Patient Preference Data... 39 5.2.4 Safety Data... 50 5.3 Protocol and Protocol Amendments... 60 STIEFEL CONFIDENTIAL Page 8

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 4 REFERENCE LIST No references cited. STIEFEL CONFIDENTIAL Page 9

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5 APPENDICES 5.1 Safety Evaluation 5.1.1 Extent of Exposure A total of 125 subjects consented and were enrolled in this study and were exposed to topical application of the study products. The mean number of days exposed to study products was 82.4 ± 13.9 days (see Section 5.2.1, Summary Table 4). The minimum exposure was 11 days, and the maximum exposure was 106 days. 5.1.2 Adverse Events (AEs) 5.1.2.1 Brief Summary of Adverse Events A total of 12 subjects (9.6%) reported experiencing at least 1 treatment-emergent AE (see Section 5.2.4, Summary Table 10.1). No subject experienced a treatment-related AE and no serious adverse events (SAE) were reported. 5.1.2.2 Display of Adverse Events The most common treatment-emergent AEs were related to the system organ class (SOC) of Infections and Infestations with 7 subjects (5.6%) experiencing such events (see Table 1 below and Section 5.2.4, Summary Table 10.1). STIEFEL CONFIDENTIAL Page 10

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 1. Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term (ITT Analysis Set) SYSTEM ORGAN CLASS Preferred Term Total (n = 125) N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 12 (9.6%) GASTROINTESTINAL DISORDERS 1 (0.8%) Gastrooesophageal Reflux Disease 1 (0.8%) IMMUNE SYSTEM DISORDERS 1 (0.8%) Seasonal Allergy 1 (0.8%) INFECTIONS AND INFESTATIONS 7 (5.6%) Nasopharyngitis 3 (2.4%) Oral Herpes 2 (1.6%) Pharyngitis Streptococcal 1 (0.8%) Post Procedural Infection 1 (0.8%) Sinusitis 1 (0.8%) Upper Respiratory Tract Infection 1 (0.8%) Vulvovaginal Mycotic Infection 1 (0.8%) INJURY, POISONING AND PROCEDURAL COMPLICATIONS 1 (0.8%) Contusion 1 (0.8%) NERVOUS SYSTEM DISORDERS 1 (0.8%) Burning Sensation 1 (0.8%) REPRODUCTIVE SYSTEM AND BREAST DISORDERS 1 (0.8%) Ovarian Cyst 1 (0.8%) RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 1 (0.8%) Rhinitis Allergic 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) Rash 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 11

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.1.2.3 Analysis of Adverse Events Study products were safe and well tolerated with no treatment-related AE being noted. 5.1.2.4 Listing of Adverse Events by Subject Listings will be provided upon request. 5.1.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events 5.1.3.1 Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events were reported. 5.1.3.2 Narratives of Deaths, Other Serious Adverse Events, and Certain Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events have yet been reported. 5.1.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events have yet been reported. 5.1.4 Clinical Laboratory Evaluation Clinical laboratory evaluations were not included as part of study procedures, but may be recorded in support of adverse event diagnosis or follow up. 5.1.5 Vital Signs, Physical Findings, and Other Observations Related to Safety Vital signs and physical examinations were not recorded as part of study procedures, but may be recorded in support of adverse event diagnosis or follow up. 5.1.6 Safety Conclusions MaxClarity was well tolerated with no treatment-related AEs or SAEs reported during the study. STIEFEL CONFIDENTIAL Page 12

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2 Tables, Figures and Graphs Referred to but not Included in the Text 5.2.1 Subject Disposition and Demographic Data Table Number Table 1 Table 2 Table 3 Table 4 Table Title Subject Disposition - ITT Analysis Set Demographics - ITT Analysis Set Baseline Disease Characteristics - ITT Analysis Set Treatment Duration ITT Analysis Set STIEFEL CONFIDENTIAL Page 13

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 1: Subject Disposition ITT Analysis Set Subject Disposition MaxClarity (n = 125) N (%) Completed 115 (92.0%) Discontinued 10 (8.0%) Reasons for Discontinuation FSI = 23JUN2011; LSI = 14SEP2011; LSO = 14DEC2011 Output: U0289-405 Table 1.rtf Program: U0289-405 Table 1.sas Source: Datasets DS and SV Adverse Event 1 (10.0%) Lost to Follow Up 2 (20.0%) Withdrawal of Consent 7 (70.0%) STIEFEL CONFIDENTIAL Page 14

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 2: Demographics ITT Analysis Set MaxClarity (n = 125) Age (years) N 125 Mean ± SD 19.0 ± 5.7 Median (P25, P75) 16.9 (15.1, 20.8) Min, Max 12.1, 35.7 Sex, n (%) Male 57 (45.6%) Female 68 (54.4%) Race, n (%) American Indian or Alaskan Native 7 (5.6%) Asian 9 (7.2%) Black 21 (16.8%) Native Hawaiian or Other Pacific Islander 1 (0.8%) White 84 (67.2%) Other 3 (2.4%) Ethnicity, n (%) Hispanic or Latino 27 (21.6%) Not Hispanic or Latino 98 (78.4%) Output: U0289-405 Table 2.rtf Program: U0289-405 Table 2.sas Source: Dataset DM STIEFEL CONFIDENTIAL Page 15

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 3: Baseline Disease Characteristics ITT Analysis Set Investigator Static Global Assessment, n (%) MaxClarity (n = 125) 3- Moderate 84 (67.2%) 4- Severe 41 (32.8%) Inflammatory Lesion Count N 125 Mean ± SD 32.2 ± 6.7 Median (P25, P75) 29.0 (27.0, 37.0) Min, Max 25.0, 50.0 Non-Inflammatory Lesion Count N 125 Mean ± SD 46.5 ± 21.0 Median (P25, P75) 41.0 (28.0, 58.0) Min, Max 21.0, 97.0 Total Lesion Count N 125 Mean ± SD 78.7 ± 24.5 Median (P25, P75) 75.0 (57.0, 92.0) Min, Max 47.0, 146.0 Post-Inflammatory Hyperpigmentation Severity, n (%) 0- Absent 51 (40.8%) 1- Slight 15 (12.0%) 2- Mild 41 (32.8%) 3- Moderate 17 (13.6%) 4- Moderately Severe 1 (0.8%) Post-Inflammatory Hyperpigmentation Distribution, n (%) 0- None 54 (43.2%) 1-1-10% of the face 27 (21.6%) 2-11-20% of the face 32 (25.6%) 3-21-30% of the face 11 (8.8%) 4-31-40% of the face 1 (0.8%) Output: U0289-405 Table 3.rtf Program: U0289-405 Table 3.sas Source: Dataset EF_BSL STIEFEL CONFIDENTIAL Page 16

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 4: Study Product Exposure ITT Analysis Set Treatment duration (days) 1 MaxClarity (n = 125) N 124 Mean ± SD 82.4 ± 13.9 Median (P25, P75) 85.0 (84.0, 86.0) Min, Max 11.0, 106.0 Missing values 1 Treatment duration (categories), n (%) >=4 weeks 120 (96.8%) >=8 weeks 119 (96.0%) >=12 weeks 99 (79.8%) 1 Time (in days) between first and last treatment applications + 1 Output: U0289-405 Table 4.rtf Program: U0289-405 Table 4.sas Source: Dataset MD STIEFEL CONFIDENTIAL Page 17

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.2 Efficacy Data Table Number Table 5.1 Table 5.2 Table 5.3 Table 6 Table 7.1 Table 7.2 Table 8 Table Title Lesion Counts Inflammatory Lesions ITT Analysis Set Lesion Counts Non-Inflammatory Lesions ITT Analysis Set Lesion Counts Total Lesions ITT Analysis Set Investigator Static Global Assessment ITT Analysis Set Post-Inflammatory Hyperpigmentation Assessments Severity ITT Analysis Set Post-Inflammatory Hyperpigmentation Assessments Distribution ITT Analysis Set Subject s Global Improvement Scale ITT Analysis Set STIEFEL CONFIDENTIAL Page 18

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.1: Lesion Counts Inflammatory Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 32.2 ± 6.7 Median (P25, P75) 29.0 (27.0, 37.0) Min, Max 25.0, 50.0 Week 1 N 120 Mean ± SD 22.6 ± 10.0 Median (P25, P75) 22.0 (17.0, 28.5) Min, Max 0.0, 50.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -9.6 ± 8.2 Median (P25, P75) -8.0 (-14.5, -3.0) Min, Max -35.0, 9.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -30.4 ± 25.8 Median (P25, P75) -28.6 (-48.1, -11.4) Min, Max -100.0, 25.7 Missing values 5 Week 2 N 121 Mean ± SD 18.0 ± 10.0 Median (P25, P75) 17.0 (11.0, 23.0) Min, Max 2.0, 52.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -14.3 ± 8.9 Median (P25, P75) -14.0 (-20.0, -8.0) Min, Max -41.0, 12.0 Missing values 4 STIEFEL CONFIDENTIAL Page 19

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.1: Lesion Counts (Continued) Inflammatory Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -44.8 ± 26.4 Median (P25, P75) -44.8 (-64.4, -25.9) Min, Max -93.1, 30.0 Missing values 4 Week 4 N 120 Mean ± SD 15.3 ± 9.8 Median (P25, P75) 14.0 (8.0, 20.0) Min, Max 0.0, 53.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -16.9 ± 9.3 Median (P25, P75) -17.5 (-23.5, -10.0) Min, Max -47.0, 4.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -52.9 ± 27.0 Median (P25, P75) -55.6 (-74.5, -34.3) Min, Max -100.0, 11.4 Missing values 5 Week 8 N 116 Mean ± SD 13.4 ± 9.3 Median (P25, P75) 12.0 (6.0, 18.0) Min, Max 0.0, 52.0 Missing values 9 Change from Baseline to Week 8 N 116 Mean ± SD -18.9 ± 8.0 Median (P25, P75) -19.0 (-24.0, -14.0) Min, Max -42.0, 4.0 Missing values 9 STIEFEL CONFIDENTIAL Page 20

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 5.1: Lesion Counts (Continued) Inflammatory Lesions ITT Analysis Set MaxClarity (n = 125) % Change from Baseline to Week 8 N 116 Mean ± SD -59.8 ± 23.7 Median (P25, P75) -59.6 (-79.0, -44.4) Min, Max -100.0, 11.4 Missing values 9 Week 12/Early Termination N 122 Mean ± SD 10.9 ± 8.6 Median (P25, P75) 9.0 (5.0, 16.0) Min, Max 0.0, 51.0 Missing values 3 Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -21.4 ± 8.2 Median (P25, P75) -22.0 (-26.0, -18.0) Min, Max -45.0, 3.0 Missing values 3 % Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -67.1 ± 22.7 Median (P25, P75) -70.6 (-84.4, -55.3) Min, Max -100.0, 7.5 Missing values 3 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS STIEFEL CONFIDENTIAL Page 21

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.2: Lesion Counts Non-Inflammatory Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 46.5 ± 21.0 Median (P25, P75) 41.0 (28.0, 58.0) Min, Max 21.0, 97.0 Week 1 N 120 Mean ± SD 39.0 ± 20.2 Median (P25, P75) 32.0 (25.0, 50.0) Min, Max 13.0, 96.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -7.4 ± 12.1 Median (P25, P75) -6.0 (-13.0, 0.0) Min, Max -43.0, 25.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -14.8 ± 24.4 Median (P25, P75) -14.3 (-31.0, 0.0) Min, Max -70.9, 78.6 Missing values 5 Week 2 N 121 Mean ± SD 33.0 ± 19.6 Median (P25, P75) 26.0 (20.0, 41.0) Min, Max 5.0, 94.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -13.4 ± 13.5 Median (P25, P75) -10.0 (-21.0, -5.0) Min, Max -63.0, 18.0 Missing values 4 STIEFEL CONFIDENTIAL Page 22

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 5.2: Lesion Counts (Continued) Non-Inflammatory Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -28.5 ± 24.4 Median (P25, P75) -27.3 (-44.2, -14.6) Min, Max -89.3, 31.8 Missing values 4 Week 4 N 120 Mean ± SD 29.2 ± 18.7 Median (P25, P75) 24.5 (15.0, 38.0) Min, Max 5.0, 95.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -17.6 ± 15.4 Median (P25, P75) -17.5 (-27.5, -8.5) Min, Max -57.0, 21.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -37.1 ± 30.1 Median (P25, P75) -42.9 (-58.4, -21.5) Min, Max -87.8, 51.2 Missing values 5 Week 8 N 116 Mean ± SD 26.5 ± 19.0 Median (P25, P75) 21.0 (13.0, 33.5) Min, Max 3.0, 99.0 Missing values 9 Change from Baseline to Week 8 N 116 Mean ± SD -20.1 ± 16.3 Median (P25, P75) -18.0 (-31.5, -10.0) Min, Max -60.0, 41.0 Missing values 9 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS STIEFEL CONFIDENTIAL Page 23

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.2: Lesion Counts (Continued) Non-Inflammatory Lesions ITT Analysis Set MaxClarity (n = 125) % Change from Baseline to Week 8 N 116 Mean ± SD -43.8 ± 29.3 Median (P25, P75) -46.4 (-64.6, -30.0) Min, Max -90.6, 70.7 Missing values 9 Week 12/Early Termination N 122 Mean ± SD 21.1 ± 17.5 Median (P25, P75) 14.0 (9.0, 27.0) Min, Max 0.0, 93.0 Missing values 3 Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -25.6 ± 15.3 Median (P25, P75) -22.0 (-36.0, -15.0) Min, Max -73.0, 12.0 Missing values 3 % Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -57.3 ± 25.8 Median (P25, P75) -61.1 (-76.3, -45.9) Min, Max -100.0, 30.0 Missing values 3 STIEFEL CONFIDENTIAL Page 24

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.3: Lesion Counts Total Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 78.7 ± 24.5 Median (P25, P75) 75.0 (57.0, 92.0) Min, Max 47.0, 146.0 Week 1 N 120 Mean ± SD 61.6 ± 26.8 Median (P25, P75) 54.0 (43.0, 76.0) Min, Max 16.0, 132.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -17.0 ± 16.6 Median (P25, P75) -13.5 (-28.0, -5.0) Min, Max -59.0, 25.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -22.2 ± 20.6 Median (P25, P75) -18.5 (-35.9, -7.4) Min, Max -73.8, 28.7 Missing values 5 Week 2 N 121 Mean ± SD 50.9 ± 26.1 Median (P25, P75) 45.0 (32.0, 66.0) Min, Max 7.0, 123.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -27.7 ± 18.8 Median (P25, P75) -22.0 (-40.0, -15.0) Min, Max -104.0, 8.0 Missing values 4 STIEFEL CONFIDENTIAL Page 25

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.3: Lesion Counts (Continued) Total Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -36.0 ± 21.5 Median (P25, P75) -34.5 (-51.5, -21.4) Min, Max -88.4, 9.3 Missing values 4 Week 4 N 120 Mean ± SD 44.4 ± 25.1 Median (P25, P75) 40.0 (25.5, 57.5) Min, Max 8.0, 131.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -34.5 ± 20.3 Median (P25, P75) -32.0 (-49.0, -22.5) Min, Max -87.0, 22.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -44.4 ± 23.6 Median (P25, P75) -45.7 (-62.4, -28.5) Min, Max -91.6, 25.6 Missing values 5 Week 8 N 116 Mean ± SD 39.8 ± 25.1 Median (P25, P75) 32.5 (20.5, 53.5) Min, Max 6.0, 120.0 Missing values 9 Change from Baseline to Week 8 N 116 Mean ± SD -38.9 ± 20.4 Median (P25, P75) -35.0 (-52.0, -27.5) Min, Max -100.0, 33.0 Missing values 9 STIEFEL CONFIDENTIAL Page 26

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.3: Lesion Counts (Continued) Total Lesions ITT Analysis Set MaxClarity (n = 125) % Change from Baseline to Week 8 N 116 Mean ± SD -51.0 ± 23.2 Median (P25, P75) -53.5 (-68.2, -36.4) Min, Max -89.7, 38.4 Missing values 9 Week 12/Early Termination N 122 Mean ± SD 32.0 ± 23.4 Median (P25, P75) 25.0 (14.0, 41.0) Min, Max 0.0, 108.0 Missing values 3 Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -47.0 ± 19.8 Median (P25, P75) -45.0 (-59.0, -35.0) Min, Max -109.0, 1.0 Missing values 3 % Change from Baseline to Week 12/Early Termination N 122 Mean ± SD -61.6 ± 22.0 Median (P25, P75) -65.6 (-80.4, -48.2) Min, Max -100.0, 1.5 Missing values 3 STIEFEL CONFIDENTIAL Page 27

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 6.rtf Program: U0289-405 Table 6.sas Source: Datasets EF_BSL & EF_VISITS Table 6: Investigator Static Global Assessment ITT Analysis Set Total (n = 125) Baseline (Day 1), n (%) 3- Moderate 84 (67.2%) 4- Severe 41 (32.8%) Mean ± SD 3.33 ± 0.47 Median (P25, P75) 3.00 (3.00, 4.00) Min, Max 3.00, 4.00 Week 1, n (%) 1- Almost Clear 1 (0.8%) 2- Mild 15 (12.5%) 3- Moderate 83 (69.2%) 4- Severe 21 (17.5%) Mean ± SD 3.03 ± 0.58 Median (P25, P75) 3.00 (3.00, 3.00) Min, Max 1.00, 4.00 Missing values 5 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 1 (0.8%) Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.29 ± 0.51 Median (P25, P75) 0.00 (-1.00, 0.00) Min, Max -2.00, 0.00 Missing values 5 At least one-grade improvement, n (%) 32 (26.7%) At least two-grade improvement, n (%) 3 (2.5%) Week 2, n (%) 1- Almost Clear 2 (1.7%) 2- Mild 27 (22.3%) 3- Moderate 77 (63.6%) 4- Severe 15 (12.4%) Mean ± SD 2.87 ± 0.63 Median (P25, P75) 3.00 (3.00, 3.00) Min, Max 1.00, 4.00 Missing values 4 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 2 (1.7%) STIEFEL CONFIDENTIAL Page 28

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 6.rtf Program: U0289-405 Table 6.sas Source: Datasets EF_BSL & EF_VISITS Table 6: Investigator Static Global Assessment (Continued) ITT Analysis Set Total (n = 125) Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.45 ± 0.61 Median (P25, P75) 0.00 (-1.00, 0.00) Min, Max -2.00, 1.00 Missing values 4 At least one-grade improvement, n (%) 50 (41.3%) At least two-grade improvement, n (%) 6 (5.0%) Week 4, n (%) 1- Almost Clear 4 (3.3%) 2- Mild 40 (33.3%) 3- Moderate 65 (54.2%) 4- Severe 11 (9.2%) Mean ± SD 2.69 ± 0.68 Median (P25, P75) 3.00 (2.00, 3.00) Min, Max 1.00, 4.00 Missing values 5 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 4 (3.3%) Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.63 ± 0.69 Median (P25, P75) -1.00 (-1.00, 0.00) Min, Max -3.00, 0.00 Missing values 5 At least one-grade improvement, n (%) 63 (52.5%) At least two-grade improvement, n (%) 12 (10.0%) Week 8, n (%) 1- Almost Clear 10 (8.6%) 2- Mild 44 (37.9%) 3- Moderate 53 (45.7%) 4- Severe 9 (7.8%) Mean ± SD 2.53 ± 0.76 Median (P25, P75) 3.00 (2.00, 3.00) Min, Max 1.00, 4.00 Missing values 9 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 10 (8.6%) STIEFEL CONFIDENTIAL Page 29

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 6.rtf Program: U0289-405 Table 6.sas Source: Datasets EF_BSL & EF_VISITS Table 6: Investigator Static Global Assessment (Continued) ITT Analysis Set MaxClarity (n = 125) Change from Baseline to Week 8, n (%) N 116 Mean ± SD -0.79 ± 0.75 Median (P25, P75) -1.00 (-1.00, 0.00) Min, Max -3.00, 0.00 Missing values 9 At least one-grade improvement, n (%) 71 (61.2%) At least two-grade improvement, n (%) 19 (16.4%) Week 12, n (%) 0- Clear 1 (0.8%) 1- Almost Clear 19 (15.6%) 2- Mild 55 (45.1%) 3- Moderate 39 (32.0%) 4- Severe 8 (6.6%) Mean ± SD 2.28 ± 0.84 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 3 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 20 (16.4%) Change from Baseline to Week 12, n (%) N 122 Mean ± SD -1.05 ± 0.78 Median (P25, P75) -1.00 (-2.00, -1.00) Min, Max -3.00, 1.00 Missing values 3 At least one-grade improvement, n (%) 94 (77.0%) At least two-grade improvement, n (%) 31 (25.4%) STIEFEL CONFIDENTIAL Page 30

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.1: Post-Inflammatory Hyperpigmentation Assessments Severity ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Baseline (Day 1), n (%) 0- Absent 51 (40.8%) 1- Slight 15 (12.0%) 2- Mild 41 (32.8%) 3- Moderate 17 (13.6%) 4- Moderately Severe 1 (0.8%) Mean ± SD 1.22 ± 1.15 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Week 1, n (%) 0- Absent 47 (39.2%) 1- Slight 18 (15.0%) 2- Mild 40 (33.3%) 3- Moderate 15 (12.5%) Mean ± SD 1.19 ± 1.09 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.03 ± 0.35 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 5 Week 2, n (%) 0- Absent 50 (41.3%) 1- Slight 19 (15.7%) 2- Mild 36 (29.8%) 3- Moderate 16 (13.2%) Mean ± SD 1.15 ± 1.11 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 4 Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.05 ± 0.58 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 3.00 Missing values 4 STIEFEL CONFIDENTIAL Page 31

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.1: Post-Inflammatory Hyperpigmentation Assessments (Continued) Severity ITT Analysis Set Total (n = 125) Week 4, n (%) 0- Absent 52 (43.3%) 1- Slight 21 (17.5%) 2- Mild 34 (28.3%) 3- Moderate 12 (10.0%) 4- Moderately Severe 1 (0.8%) Mean ± SD 1.08 ± 1.09 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Missing values 5 Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.12 ± 0.51 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 2.00 Missing values 5 Week 8, n (%) 0- Absent 52 (44.8%) 1- Slight 19 (16.4%) 2- Mild 38 (32.8%) 3- Moderate 7 (6.0%) Mean ± SD 1.00 ± 1.01 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 9 Change from Baseline to Week 8, n (%) N 116 Mean ± SD -0.18 ± 0.55 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 2.00 Missing values 9 Week 12, n (%) 0- Absent 56 (45.9%) 1- Slight 27 (22.1%) 2- Mild 33 (27.0%) 3- Moderate 6 (4.9%) Mean ± SD 0.91 ± 0.96 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 3 Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS STIEFEL CONFIDENTIAL Page 32

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.1: Post-Inflammatory Hyperpigmentation Assessments (Continued) Severity ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS MaxClarity (n = 125) Change from Baseline to Week 12, n (%) N 122 Mean ± SD -0.29 ± 0.58 Median (P25, P75) 0.00 (-1.00, 0.00) Min, Max -2.00, 1.00 Missing values 3 STIEFEL CONFIDENTIAL Page 33

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.2: Post-Inflammatory Hyperpigmentation Assessments Distribution ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Baseline (Day 1), n (%) 0- None 54 (43.2%) 1-1-10% of the face 27 (21.6%) 2-11-20% of the face 32 (25.6%) 3-21-30% of the face 11 (8.8%) 4-31-40% of the face 1 (0.8%) Mean ± SD 1.02 ± 1.06 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Week 1, n (%) 0- None 51 (42.5%) 1-1-10% of the face 28 (23.3%) 2-11-20% of the face 30 (25.0%) 3-21-30% of the face 11 (9.2%) Mean ± SD 1.01 ± 1.02 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.03 ± 0.27 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -1.00, 1.00 Missing values 5 Week 2, n (%) 0- None 55 (45.5%) 1-1-10% of the face 26 (21.5%) 2-11-20% of the face 29 (24.0%) 3-21-30% of the face 11 (9.1%) Mean ± SD 0.97 ± 1.03 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 4 Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.06 ± 0.32 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -1.00, 1.00 Missing values 4 STIEFEL CONFIDENTIAL Page 34

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.2: Post-Inflammatory Hyperpigmentation Assessments (Continued) Distribution ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Week 4, n (%) 0- None 55 (45.8%) 1-1-10% of the face 31 (25.8%) 2-11-20% of the face 24 (20.0%) 3-21-30% of the face 10 (8.3%) Mean ± SD 0.91 ± 1.00 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.11 ± 0.38 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 5 Week 8, n (%) 0- None 54 (46.6%) 1-1-10% of the face 29 (25.0%) 2-11-20% of the face 26 (22.4%) 3-21-30% of the face 7 (6.0%) Mean ± SD 0.88 ± 0.96 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 9 Change from Baseline to Week 8, n (%) N 116 Mean ± SD -0.13 ± 0.41 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 9 Week 12, n (%) 0- None 58 (47.5%) 1-1-10% of the face 35 (28.7%) 2-11-20% of the face 24 (19.7%) 3-21-30% of the face 5 (4.1%) Mean ± SD 0.80 ± 0.90 Median (P25, P75) 1.00 (0.00, 1.00) Min, Max 0.00, 3.00 Missing values 3 STIEFEL CONFIDENTIAL Page 35

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.2: Post-Inflammatory Hyperpigmentation Assessments (Continued) Distribution ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS MaxClarity (n = 125) Change from Baseline to Week 12, n (%) N 122 Mean ± SD -0.21 ± 0.53 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 3 STIEFEL CONFIDENTIAL Page 36

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 8.rtf Program: U0289-405 Table 8.sas Source: Dataset EF_VISITS Table 8: Subject's Global Improvement Scale ITT Analysis Set Total (n = 125) Week 1, n (%) 0- Worse 8 (6.7%) 1- Same 15 (12.5%) 2- Mild Improvement 76 (63.3%) 3- Obvious Improvement 17 (14.2%) 4- Marked Improvement 4 (3.3%) Mean ± SD 1.95 ± 0.82 Median (P25, P75) 2.00 (2.00, 2.00) Min, Max 0.00, 4.00 Missing values 5 Week 2, n (%) 0- Worse 3 (2.5%) 1- Same 23 (19.0%) 2- Mild Improvement 61 (50.4%) 3- Obvious Improvement 30 (24.8%) 4- Marked Improvement 4 (3.3%) Mean ± SD 2.07 ± 0.82 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 4 Week 4, n (%) 0- Worse 4 (3.3%) 1- Same 11 (9.2%) 2- Mild Improvement 61 (50.8%) 3- Obvious Improvement 36 (30.0%) 4- Marked Improvement 8 (6.7%) Mean ± SD 2.28 ± 0.85 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 5 Week 8, n (%) 0- Worse 5 (4.3%) 1- Same 9 (7.8%) 2- Mild Improvement 51 (44.0%) 3- Obvious Improvement 44 (37.9%) 4- Marked Improvement 7 (6.0%) Mean ± SD 2.34 ± 0.87 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 9 STIEFEL CONFIDENTIAL Page 37

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 8.rtf Program: U0289-405 Table 8.sas Source: Dataset EF_VISITS Table 8: Subject's Global Improvement Scale (Continued) ITT Analysis Set MaxClarity (n = 125) Week 12, n (%) 0- Worse 4 (3.3%) 1- Same 11 (9.0%) 2- Mild Improvement 39 (32.0%) 3- Obvious Improvement 48 (39.3%) 4- Marked Improvement 20 (16.4%) Mean ± SD 2.57 ± 0.98 Median (P25, P75) 3.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 3 STIEFEL CONFIDENTIAL Page 38

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.3 Patient Preference Data Table Number Table 9.1 Table 9.2 Table 9.3 Table 9.4 Table 9.5 Table Title Subject s Preference Post-Study Questionnaire - Features Subject s Preference Post-Study Questionnaire Product - Statements Subject s Preference Post-Study Questionnaire - Acne Products Used in Past Subject s Preference Post-Study Questionnaire - Rating of Qualities of Foam Subject s Preference Post-Study Questionnaire - Foam Rating STIEFEL CONFIDENTIAL Page 39

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.1: Subject s Preference Post-Study Questionnaire Features ITT Analysis Set MaxClarity (n = 125) Less Embarrassed, n (%) 1 - Strongly disagree 5 (4.1%) 2 - Disagree 5 (4.1%) 3 - Neutral 45 (36.9%) 4 - Agree 54 (44.3%) 5 - Strongly agree 13 (10.7%) Missing 3 Mean ± SD 3.53 ± 0.89 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Less Self-Conscious, n (%) 1 - Strongly disagree 6 (4.9%) 2 - Disagree 10 (8.2%) 3 - Neutral 30 (24.6%) 4 - Agree 67 (54.9%) 5 - Strongly agree 9 (7.4%) Missing 3 Mean ± SD 3.52 ± 0.93 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 More at Ease, n (%) 1 - Strongly disagree 3 (2.5%) 2 - Disagree 7 (5.7%) 3 - Neutral 39 (32.0%) 4 - Agree 58 (47.5%) 5 - Strongly agree 15 (12.3%) Missing 3 Mean ± SD 3.61 ± 0.87 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Happier, n (%) 1 - Strongly disagree 3 (2.5%) 2 - Disagree 6 (4.9%) 3 - Neutral 40 (32.8%) 4 - Agree 56 (45.9%) 5 - Strongly agree 17 (13.9%) Missing 3 Mean ± SD 3.64 ± 0.87 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST STIEFEL CONFIDENTIAL Page 40

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.1: Subject s Preference Post-Study Questionnaire (Continued) Features ITT Analysis Set MaxClarity (n = 125) More Self-Confident, n (%) 1 - Strongly disagree 4 (3.3%) 2 - Disagree 8 (6.6%) 3 - Neutral 41 (33.6%) 4 - Agree 49 (40.2%) 5 - Strongly agree 20 (16.4%) Missing 3 Mean ± SD 3.60 ± 0.95 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 More like myself, n (%) 1 - Strongly disagree 1 (0.8%) 2 - Disagree 10 (8.2%) 3 - Neutral 47 (38.5%) 4 - Agree 45 (36.9%) 5 - Strongly agree 19 (15.6%) Missing 3 Mean ± SD 3.58 ± 0.88 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Less Frustrated, n (%) 1 - Strongly disagree 6 (4.9%) 2 - Disagree 16 (13.1%) 3 - Neutral 41 (33.6%) 4 - Agree 42 (34.4%) 5 - Strongly agree 17 (13.9%) Missing 3 Mean ± SD 3.39 ± 1.04 Median (P25, P75) 3.00 (3.00, 4.00) Min, Max 1.00, 5.00 More Attractive, n (%) 1 - Strongly disagree 3 (2.5%) 2 - Disagree 12 (9.8%) 3 - Neutral 43 (35.2%) 4 - Agree 49 (40.2%) 5 - Strongly agree 15 (12.3%) Missing 3 Mean ± SD 3.50 ± 0.92 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST STIEFEL CONFIDENTIAL Page 41

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.1: Subject s Preference Post-Study Questionnaire (Continued) Features ITT Analysis Set Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST MaxClarity (n = 125) More Hopeful, n (%) 1 - Strongly disagree 1 (0.8%) 2 - Disagree 7 (5.7%) 3 - Neutral 38 (31.1%) 4 - Agree 58 (47.5%) 5 - Strongly agree 18 (14.8%) Missing 3 Mean ± SD 3.70 ± 0.82 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Less Upset, n (%) 1 - Strongly disagree 3 (2.5%) 2 - Disagree 7 (5.7%) 3 - Neutral 53 (43.4%) 4 - Agree 40 (32.8%) 5 - Strongly agree 19 (15.6%) Missing 3 Mean ± SD 3.53 ± 0.91 Median (P25, P75) 3.00 (3.00, 4.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 42

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST Table 9.2: Subject s Preference Post-Study Questionnaire Product Statements ITT Analysis Set MaxClarity (n = 125) Continue to Use Study Products 1 - Strongly disagree 17 (13.9%) 2 - Disagree 11 (9.0%) 3 - Neutral 25 (20.5%) 4 - Agree 42 (34.4%) 5 - Strongly agree 27 (22.1%) Missing 3 Mean ± SD 3.42 ± 1.31 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Satisfied with Study Products 1 - Strongly disagree 11 (9.0%) 2 - Disagree 8 (6.6%) 3 - Neutral 17 (13.9%) 4 - Agree 58 (47.5%) 5 - Strongly agree 28 (23.0%) Missing 3 Mean ± SD 3.69 ± 1.16 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Easy to use with Make-Up 1 - Strongly disagree 2 (1.6%) 2 - Disagree 2 (1.6%) 3 - Neutral 3 (2.5%) 4 - Agree 30 (24.6%) 5 - Strongly agree 19 (15.6%) Not applicable, I don't wear makeup 66 (54.1%) Missing 3 Mean ± SD 4.11 ± 0.93 Median (P25, P75) 4.00 (4.00, 5.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 43

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST Table 9.3: Subject s Preference Post-Study Questionnaire Acne Products Used in Past ITT Analysis Set MaxClarity (n = 125) MaxClarity System Preference 1 - Liked the best 81 (66.9%) 2 - Liked second best 15 (12.4%) 3 - Liked third best 3 (2.5%) 4 - Liked fourth best 1 (0.8%) 5 - Liked the least 4 (3.3%) Does not apply to me 17 (14.0%) Missing 4 Mean ± SD 1.38 ± 0.91 Median (P25, P75) 1.00 (1.00, 1.00) Min, Max 1.00, 5.00 Proactiv System Preference 1 - Liked the best 10 (8.2%) 2 - Liked second best 31 (25.4%) 3 - Liked third best 5 (4.1%) 4 - Liked fourth best 2 (1.6%) 5 - Liked the least 5 (4.1%) Does not apply to me 69 (56.6%) Missing 3 Mean ± SD 2.26 ± 1.11 Median (P25, P75) 2.00 (2.00, 2.00) Min, Max 1.00, 5.00 Murad System Preference 1 - Liked the best 2 (1.6%) 2 - Liked second best 3 (2.5%) 3 - Liked third best 4 (3.3%) 4 - Liked fourth best 1 (0.8%) Does not apply to me 112 (91.8%) Missing 3 Mean ± SD 2.40 ± 0.97 Median (P25, P75) 2.50 (2.00, 3.00) Min, Max 1.00, 4.00 STIEFEL CONFIDENTIAL Page 44

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.3: Subject s Preference Post-Study Questionnaire (Continued) Acne Products Used in Past ITT Analysis Set Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST MaxClarity (n = 125) SkiniD System Preference 2 - Liked second best 1 (0.8%) 3 - Liked third best 2 (1.6%) 4 - Liked fourth best 1 (0.8%) 5 - Liked the least 1 (0.8%) Does not apply to me 117 (95.9%) Missing 3 Mean ± SD 3.40 ± 1.14 Median (P25, P75) 3.00 (3.00, 4.00) Min, Max 2.00, 5.00 Other Preference (specify) 1 - Liked the best 7 (8.5%) 2 - Liked second best 9 (11.0%) 3 - Liked third best 1 (1.2%) 5 - Liked the least 2 (2.4%) Does not apply to me 63 (76.8%) Missing 43 Mean ± SD 2.00 ± 1.20 Median (P25, P75) 2.00 (1.00, 2.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 45

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST Table 9.4: Subject s Preference Post-Study Questionnaire Rating of Qualities of Foam ITT Analysis Set MaxClarity (n = 125) Easy to Use 1 - Much Worse 1 (0.8%) 2 - Worse 8 (6.6%) 3 - About the same 27 (22.1%) 4 - Better 36 (29.5%) 5 - Much Better 39 (32.0%) Does not apply to me 11 (9.0%) Missing 3 Mean ± SD 3.94 ± 0.98 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 1.00, 5.00 Able to continue daily activities 1 - Much Worse 2 (1.6%) 2 - Worse 3 (2.5%) 3 - About the same 31 (25.4%) 4 - Better 32 (26.2%) 5 - Much Better 43 (35.2%) Does not apply to me 11 (9.0%) Missing 3 Mean ± SD 4.00 ± 0.97 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 1.00, 5.00 Leaves skin feeling soft 1 - Much Worse 2 (1.6%) 2 - Worse 13 (10.7%) 3 - About the same 33 (27.0%) 4 - Better 37 (30.3%) 5 - Much Better 26 (21.3%) Does not apply to me 11 (9.0%) Missing 3 Mean ± SD 3.65 ± 1.02 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 46

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.4: Subject s Preference Post-Study Questionnaire (Continued) Rating of Qualities of Foam ITT Analysis Set Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST MaxClarity (n = 125) Disappears into skin quickly 1 - Much Worse 6 (4.9%) 2 - Worse 5 (4.1%) 3 - About the same 20 (16.4%) 4 - Better 39 (32.0%) 5 - Much Better 41 (33.6%) Does not apply to me 11 (9.0%) Missing 3 Mean ± SD 3.94 ± 1.11 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 47

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST Table 9.5: Subject s Preference Post-Study Questionnaire Foam Rating ITT Analysis Set MaxClarity (n = 125) Moisturizing 1-Very Poor 2 (1.6%) 2-Poor 13 (10.7%) 3-Fair 35 (28.7%) 4-Good 55 (45.1%) 5-Excellent 17 (13.9%) Missing 3 Mean ± SD 3.59 ± 0.92 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Lack of residue 1-Very Poor 2 (1.6%) 2-Poor 15 (12.3%) 3-Fair 42 (34.4%) 4-Good 39 (32.0%) 5-Excellent 24 (19.7%) Missing 3 Mean ± SD 3.56 ± 1.00 Median (P25, P75) 4.00 (3.00, 4.00) Min, Max 1.00, 5.00 Does not feel greasy 2-Poor 8 (6.6%) 3-Fair 29 (23.8%) 4-Good 43 (35.2%) 5-Excellent 42 (34.4%) Missing 3 Mean ± SD 3.98 ± 0.92 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 2.00, 5.00 Absorbs quickly 1-Very Poor 1 (0.8%) 2-Poor 6 (4.9%) 3-Fair 25 (20.5%) 4-Good 52 (42.6%) 5-Excellent 38 (31.1%) Missing 3 Mean ± SD 3.98 ± 0.89 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 48

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9.5: Subject s Preference Post-Study Questionnaire (Continued) Foam Rating ITT Analysis Set Output: U0289-405 Table 9.rtf Program: U0289-405 Table 9.sas Source: Dataset QS_POST MaxClarity (n = 125) Easy to apply 2-Poor 1 (0.8%) 3-Fair 16 (13.1%) 4-Good 49 (40.2%) 5-Excellent 56 (45.9%) Missing 3 Mean ± SD 4.31 ± 0.73 Median (P25, P75) 4.00 (4.00, 5.00) Min, Max 2.00, 5.00 Fragrance free 2-Poor 5 (4.1%) 3-Fair 19 (15.6%) 4-Good 55 (45.1%) 5-Excellent 43 (35.2%) Missing 3 Mean ± SD 4.11 ± 0.82 Median (P25, P75) 4.00 (4.00, 5.00) Min, Max 2.00, 5.00 Spreadability 2-Poor 1 (0.8%) 3-Fair 15 (12.3%) 4-Good 52 (42.6%) 5-Excellent 54 (44.3%) Missing 3 Mean ± SD 4.30 ± 0.71 Median (P25, P75) 4.00 (4.00, 5.00) Min, Max 2.00, 5.00 Lack of stickiness 1-Very Poor 3 (2.5%) 2-Poor 9 (7.4%) 3-Fair 22 (18.0%) 4-Good 39 (32.0%) 5-Excellent 49 (40.2%) Missing 3 Mean ± SD 4.00 ± 1.05 Median (P25, P75) 4.00 (3.00, 5.00) Min, Max 1.00, 5.00 STIEFEL CONFIDENTIAL Page 49

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.4 Safety Data Table Number Table 10.1 Table 10.2 Table 10.3 Table 10.4 Table 10.5 Table 10.6 Table 11 Table Title Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Treatment-Emergent Adverse Events Classified by Preferred Term in Descending Order of Frequency ITT Analysis Set Incidence of Treatment-Related Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Severe Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Treatment-Emergent Adverse Events Resulting in Discontinuation Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Serious Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Prevalence of Concomitant Medication Use Classified by 2nd ATC level and Preferred Term ITT Analysis Set STIEFEL CONFIDENTIAL Page 50

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.1: Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set MaxClarity (n = 125) SYSTEM ORGAN CLASS Preferred Term N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 12 (9.6%) GASTROINTESTINAL DISORDERS 1 (0.8%) GASTROOESOPHAGEAL REFLUX DISEASE 1 (0.8%) IMMUNE SYSTEM DISORDERS 1 (0.8%) SEASONAL ALLERGY 1 (0.8%) INFECTIONS AND INFESTATIONS 7 (5.6%) NASOPHARYNGITIS 3 (2.4%) ORAL HERPES 2 (1.6%) PHARYNGITIS STREPTOCOCCAL 1 (0.8%) POST PROCEDURAL INFECTION 1 (0.8%) SINUSITIS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) VULVOVAGINAL MYCOTIC INFECTION 1 (0.8%) INJURY, POISONING AND PROCEDURAL COMPLICATIONS 1 (0.8%) CONTUSION 1 (0.8%) NERVOUS SYSTEM DISORDERS 1 (0.8%) BURNING SENSATION 1 (0.8%) REPRODUCTIVE SYSTEM AND BREAST DISORDERS 1 (0.8%) OVARIAN CYST 1 (0.8%) RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 1 (0.8%) RHINITIS ALLERGIC 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) RASH 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 51

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.2: Incidence of Treatment-Emergent Adverse Events Classified by Preferred Term in Descending Order of Frequency ITT Analysis Set MaxClarity (n = 125) PREFERRED TERM N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 12 (9.6%) NASOPHARYNGITIS 3 (2.4%) ORAL HERPES 2 (1.6%) BURNING SENSATION 1 (0.8%) CONTUSION 1 (0.8%) GASTROOESOPHAGEAL REFLUX DISEASE 1 (0.8%) OVARIAN CYST 1 (0.8%) PHARYNGITIS STREPTOCOCCAL 1 (0.8%) POST PROCEDURAL INFECTION 1 (0.8%) RASH 1 (0.8%) RHINITIS ALLERGIC 1 (0.8%) SEASONAL ALLERGY 1 (0.8%) SINUSITIS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) VULVOVAGINAL MYCOTIC INFECTION 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 52

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.3: Incidence of Treatment-Related Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set No Treatment-Related Adverse Event was reported during this Study. Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 53

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.4: Incidence of Severe Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set MaxClarity (n = 125) SYSTEM ORGAN CLASS Preferred Term N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 1 (0.8%) INFECTIONS AND INFESTATIONS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 54

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.5: Incidence of Treatment-Emergent Adverse Events Resulting in Discontinuation Classified by System Organ Class and Preferred Term ITT Analysis Set MaxClarity (n = 125) SYSTEM ORGAN CLASS Preferred Term N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) RASH 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 55

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.6: Incidence of Serious Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set No Serious Adverse Event was reported during this Study. Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 56

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use Classified by 2nd ATC Level and Preferred Term ITT Analysis Set MaxClarity (n = 125) DRUG CLASSIFICATION N (%) Medication ADRENERGICS AND OTH.DRUGS FOR OBSTRUCT.AIRWAY DIS. 1 (0.8%) Seretide 1 (0.8%) AMINOALKYL ETHERS 5 (4.0%) Diphenhydramine 5 (4.0%) ANILIDES 5 (4.0%) Benadryl cold and flu 1 (0.8%) Pamprin 1 (0.8%) Paracetamol 2 (1.6%) Thomapyrin n 1 (0.8%) ANTIALLERGIC AGENTS, EXCL. CORTICOSTEROIDS 1 (0.8%) Olopatadine 1 (0.8%) ANTIINFECTIVES FOR TREATMENT OF ACNE 2 (1.6%) Clindamycin 1 (0.8%) Doxycycline 1 (0.8%) ANTIVIRALS 1 (0.8%) Aciclovir 1 (0.8%) BETA BLOCKING AGENTS, SELECTIVE 2 (1.6%) Metoprolol 2 (1.6%) CALCIUM 1 (0.8%) Calcium carbonate 1 (0.8%) CARBAMIDE PRODUCTS 1 (0.8%) Urea 1 (0.8%) CENTRALLY ACTING SYMPATHOMIMETICS 6 (4.8%) Lisdexamfetamine 1 (0.8%) Methylphenidate 3 (2.4%) Obetrol 2 (1.6%) COMB OF PENICILLINS, INCL. BETA-LACTAMASE INHIB. 1 (0.8%) Augmentin 1 (0.8%) COMB.SULFONAMIDES & TRIMETHOPRIM INCL. DERIVATIVES 1 (0.8%) Bactrim 1 (0.8%) CORTICOSTEROIDS 2 (1.6%) Fluticasone 2 (1.6%) CORTICOSTEROIDS, POTENT (GROUP III) 2 (1.6%) Betamethasone 1 (0.8%) Fluocinonide 1 (0.8%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 57

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use (Continued) Classified by 2nd ATC Level and Preferred Term ITT Analysis Set MaxClarity (n = 125) CORTICOSTEROIDS, VERY POTENT (GROUP IV) 1 (0.8%) Clobetasol 1 (0.8%) DIPHENYLMETHANE DERIVATIVES 1 (0.8%) Hydroxyzine 1 (0.8%) EXPECTORANTS 1 (0.8%) Guaifenesin 1 (0.8%) GLUCOCORTICOIDS 1 (0.8%) Fluticasone 1 (0.8%) H2-RECEPTOR ANTAGONISTS 1 (0.8%) Famotidine 1 (0.8%) IMIDAZOLE AND TRIAZOLE DERIVATIVES 1 (0.8%) Ketoconazole 1 (0.8%) IMIDAZOLE DERIVATIVES 1 (0.8%) Miconazole 1 (0.8%) INSULINS AND ANALOGUES 1 (0.8%) Insulin 1 (0.8%) INTRAUTERINE CONTRACEPTIVES 2 (1.6%) Intrauterine contraceptive device 2 (1.6%) INTRAVAGINAL CONTRACEPTIVES 11 (8.8%) Intravaginal contraceptives 11 (8.8%) MACROLIDES 1 (0.8%) Azithromycin 1 (0.8%) MULTIVITAMINS WITH MINERALS 2 (1.6%) Multivitamins plus iron 1 (0.8%) Prenatal vitamins 1 (0.8%) MULTIVITAMINS, PLAIN 10 (8.0%) Multivitamin 10 (8.0%) NATURAL OPIUM ALKALOIDS 1 (0.8%) Panadeine co 1 (0.8%) OTHER ANTIDEPRESSANTS 3 (2.4%) Bupropion 1 (0.8%) Trazodone 2 (1.6%) OTHER ANTIEPILEPTICS 1 (0.8%) Lamotrigine 1 (0.8%) Zonisamide 1 (0.8%) OTHER ANTIFUNGALS FOR TOPICAL USE 1 (0.8%) Naftifine 1 (0.8%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 58

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use (Continued) Classified by 2nd ATC Level and Preferred Term ITT Analysis Set MaxClarity (n = 125) OTHER ANTIHISTAMINES FOR SYSTEMIC USE 3 (2.4%) Fexofenadine 2 (1.6%) Loratadine 1 (0.8%) OTHER EMOLLIENTS AND PROTECTIVES 2 (1.6%) Dimeticone 1 (0.8%) Other emollients and protectives 1 (0.8%) OTHER LIPID MODIFYING AGENTS 1 (0.8%) Fish oil 1 (0.8%) OTHER NASAL PREPARATIONS 1 (0.8%) Sodium chloride 1 (0.8%) OTHER PLAIN VITAMIN PREPARATIONS 1 (0.8%) Biotin 1 (0.8%) OXICAMS 1 (0.8%) Meloxicam 1 (0.8%) PENICILLINS WITH EXTENDED SPECTRUM 1 (0.8%) Amoxicillin 1 (0.8%) PIPERAZINE DERIVATIVES 6 (4.8%) Cetirizine 6 (4.8%) PREPARATIONS CONTAINING SULFUR 1 (0.8%) Rosula 1 (0.8%) PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS 9 (7.2%) Anovlar 2 (1.6%) Cilest 4 (3.2%) Drospirenone w/ethinylestradiol 1 (0.8%) Eugynon 1 (0.8%) Norlestrin fe 1 (0.8%) PROPIONIC ACID DERIVATIVES 6 (4.8%) Ibuprofen 5 (4.0%) Naproxen 1 (0.8%) SELECTIVE BETA-2-ADRENORECEPTOR AGONISTS 4 (3.2%) Salbutamol 4 (3.2%) SELECTIVE SEROTONIN REUPTAKE INHIBITORS 4 (3.2%) Citalopram 2 (1.6%) Fluoxetine 1 (0.8%) Paroxetine 1 (0.8%) SYMPATHOMIMETICS 1 (0.8%) Pseudoephedrine 1 (0.8%) UNSPECIFIED HERBAL 2 (1.6%) Herbal preparation 2 (1.6%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 59

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.3 Protocol and Protocol Amendments STIEFEL CONFIDENTIAL Page 60

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 AN OPEN LABEL, 12 WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE MAXCLARITY SYSTEM (BENZOYL PEROXIDE 2.5%, SALICYLIC ACID 0.5%) IN SUBJECTS WITH ACNE CLINICAL STUDY REPORT U0289-405 (4 WEEK INTERIM DATA) VERSION 1.0 22 May 2012 Sponsored by: Stiefel, a GSK company 20 TW Alexander Drive Research Triangle Park North Carolina, 27709 Conducted by: Stiefel, a GSK company 20 TW Alexander Drive Research Triangle Park North Carolina, 27709 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR STIEFEL OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF STIEFEL. STIEFEL CONFIDENTIAL Page 1

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 1 TITLE PAGE An Open Label, 12 Week Study to Evaluate the Efficacy and Safety of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne Name of Investigational Product Indication Description MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA). Acne Open Label, 12-week efficacy and safety evaluation of the MaxClarity System in facial acne. Stiefel, a GSK company Sponsor Protocol/Study Number U0289-405 Development Phase Consumer Health Non-Prescription Post-Launch Study Study Initiation Date 23 June 2011 Study Completion Date Ongoing Sponsor s Responsible MD Medical Officer Consultant Stiefel, a GSK company Responsible Signatory MD Consultant Stiefel, a GSK company Date of the report 22 May 2012 This study was performed in accordance with Good Clinical Practices, including guidelines outlined by the International Conference on Harmonisation. STIEFEL CONFIDENTIAL Page 2

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 2 SYNOPSIS NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) Title of study: An Open Label, 12 Week Study to Evaluate the Efficacy and Safety of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne. Investigators: MD MD MD MD MD MD MD MD MD Publication (reference): No publications related to this study were published as of the date of this report. Study initiation/completion dates: The first subject was enrolled on 23 June 2011. The study is ongoing and the last subject is pending. Phase of Development: n/a Objectives: The primary objective was to assess the efficacy of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes MaxClarity Foam Deep Cleanser (2.5% BPO) and MaxClarity Foam Advanced Acne Treatment (2.5% BPO) and MaxClarity Foam Rejuvenating Toner (0.5% SA), in the treatment of moderate to severe acne. The secondary objective was to evaluate the safety and subject satisfaction of this treatment regimen. Methodology: This was a multi-center, open label, safety and efficacy study. One-hundred twenty (120) male/female subjects, 12 to 35 years of age, were to be enrolled into this study. The study duration is 12 weeks (84 days) with study visits occurring at baseline (day 1), week 1, week 2, week 4, week 8, and week 12. Number of subjects (planned and analyzed): 120 subjects planned; 125 enrolled and applied study medication. Diagnosis and Main Criteria for Inclusion: - Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed. - Male or female ages 12 to 35 years, inclusive, at time of consent. - Investigator s Static Global Assessment (ISGA) score of 3 or 4 at Baseline. - Lesion counts meeting all of the following criteria: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. A minimum of 20 but not more than 100 facial noninflammatory lesions (open and closed comedones) on the face, excluding nasal lesions. No more than 3 facial nodular lesions (<5 mm), with no cystic lesions. STIEFEL CONFIDENTIAL Page 3

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) - Able and willing to follow all study procedures, attend all visits, and successfully complete the study. - Female subjects of childbearing potential (CBP) required a negative pregnancy test. Sexually active women of CBP participating in the study must have been using a medically acceptable method of contraception. Duration of Study: 12 weeks. Test Product, Dose and Mode of Administration, Batch No.: Max Clarity Foam Deep Cleanser (2.5% BPO; Lot D0J567). Max Clarity Foam Advanced Acne Treatment (2.5% BPO; Lot D0J589). Max Clarity Foam Rejuvenating Toner (0.5% SA; Lot D0J571). AM regimen (wash face with Foam Deep Cleanser, pat dry, apply thin layer of Foam Advanced Acne Treatment); PM regimen (wash face with Foam Deep Cleanser, pat dry, apply Foam Rejuvenating Toner). Criteria for Evaluation: Efficacy: Primary endpoints: - Mean percent change from baseline in inflammatory, non-inflammatory and total lesion counts at each study visit. - Proportion of subjects with a minimum 2-grade improvement in ISGA from Baseline to each study visit. - Proportion of subjects with an ISGA score of 0 (clear) or 1 (almost clear) at each study visit. Secondary endpoints: - Absolute change in inflammatory, non-inflammatory and total lesion counts from Baseline to each study visit. - Mean change in ISGA from Baseline to each study visit. - Post-Inflammatory Hyper pigmentation (Overall Severity) at each study visit. - Post-Inflammatory Hyper pigmentation (Distribution of PIH; % of face affected) at each study visit. - Subject Global Improvement Scale. Patient Preference: - Subject Preference Post-Study Questionnaire. Safety: - Adverse Event reporting. - Concomitant medication use. Statistical Methods: All statistical analyses were performed on the intent-to-treat (ITT) analysis set using SAS software (version 9.2). The ITT analysis set included data from all subjects that were enrolled into the study. A formal sample size calculation was not conducted. No formal statistical hypothesis was formulated for this study. Data are presented in a descriptive fashion and as reported in the case report form (CRF). No inferential statistical testing was conducted and no estimation of missing data was performed. No particular processing for outliers was performed. Descriptive statistics are used to provide an overview of the efficacy and tolerability and safety results. For categorical parameters, the number and percentage of subjects in each category are presented. The denominator for percentage is based on the number of subjects appropriate for the purpose of analysis. For continuous parameters, descriptive statistics include n (number of subjects), mean, standard deviation (STD), median, and range. No estimation of missing data was performed. Age is calculated in years (1 year = 365.25 STIEFEL CONFIDENTIAL Page 4

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) days) from birth date to the first dose date and presented with one decimal. No particular processing for outliers was performed. Data is presented as reported in the CRF. For the final analysis, Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA, Version 14.1) by system organ class (SOC) and preferred term. Tables summarizing subject incidence of all AEs, serious AEs, severe AEs, treatment-related AEs, treatment-related serious AEs, and treatment-related severe AEs will be provided. All summaries will include treatment emergent events only. Also for the final analysis, prior and concomitant medications will be coded according to the World Health Organization Drug Dictionary (WHODrug) January 2009. Individual subject listings of all data represented on the CRF were produced, but are not included with this report. In general, one listing was produced per CRF domain which was sorted by subject number. Additional listings were prepared to support selected summary tables. Individual subject listings will be provided upon request. SUMMARY CONCLUSIONS Efficacy Results: Primary analyses: Lesion counts: At week 4, clinically significant reductions in all lesion types were seen. Mean ± SD percent reduction from baseline of -44.4 ± 23.6% in total lesions was noted. Inflammatory lesions appeared more responsive than noninflammatory lesions to study product. At week 4, reductions from baseline in inflammatory and noninflammatory lesions were -52.9 ± 27.0% and -37.1 ± 30.1%, respectively. At week 1 and week 2, clinically significant reductions from baseline were noted with all lesion outcomes (see Table 1 below and section 5.2.2, Summary Tables 5.1, 5.2 and 5.3). Table 1. Summary of Primary Efficacy Results Lesion Counts Primary Efficacy Outcomes Mean percent change in inflammatory lesion count from baseline to: Mean percent change in noninflammatory lesion count from baseline to: Mean percent change in total lesion count from baseline to: Source: Summary Tables 5.1, 5.2, 5.3, section 5.2.2. MaxClarity II (mean ± SD) week 1-30.4 ± 25.8% week 2-44.8 ± 26.4% week 4-52.9 ± 27.0% week 1-14.8 ± 24.4% week 2-28.5 ± 24.4% week 4-37.1 ± 30.1% week 1-22.2 ± 20.6% week 2-36.0 ± 21.5% week 4-44.4 ± 23.6% The proportion of subjects achieving minimal 2-grade improvement in the ISGA at week 4 was 10.0% (12/120 subjects). At week 1 and week 2, 2.5% (3/120 subjects) and 5.0% (6/121 subjects) achieved this threshold, respectively. The proportion of subjects with an IGSA score of 0 (clear) or 1 (almost clear) at week 1, week 2 and week 4 was 0.8% (1/120 subjects), 1.7% (2/121 subjects) and 3.3% (4/120 subjects), respectively (see STIEFEL CONFIDENTIAL Page 5

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid Table 1 below and section 5.2.2, Summary Table 6). INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) Table 2. Summary of Primary Efficacy Results ISGA Primary Efficacy Outcomes Proportion of subjects with a > 2-grade improvement from Baseline to: Proportion of subjects with a score of 0 (clear) or 1 (almost clear): Source: Summary Table 6, section 5.2.2. MaxClarity II n (%) week 1 3 (2.5%) week 2 6 (5.0%) week 4 12 (10.0%) week 1 1 (0.8%) week 2 2 (1.7%) week 4 4 (3.3%) Secondary analyses: Absolute change in lesion counts: At week 1, week 2, and week 4, the mean ± SD change in inflammatory lesions from baseline was -9.6 ± 8.2, -14.3 ± 8.9, and -16.9 ± 9.3 lesions, respectively. The mean change in noninflammatory lesions from baseline was -7.4 ± 12.1, -13.4 ± 13.5, and -17.6 ± 15.4 lesions at week 1, week 2, and week 4, respectively. The mean change in total lesions from baseline was -17.0 ± 16.6, -27.7 ± 18.8, and -34.5 ± 20.3 lesions at week 1, week 2, and week 4, respectively (see section 5.2.2, Summary Table 5.1, 5.2 and 5.3). Mean change in ISGA: The mean ± SD change in ISGA from baseline was -0.29 ± 0.51, -0.45 ± 0.61, and -0.63 ± 0.69 at week 1, week 2, and week 4, respectively (see section 5.2.2, Summary Table 6). Mean change in Post-Inflammatory Hyperpigmentation: The mean ± SD change from baseline in PIH Overall Severity was -0.03 ± 0.35, -0.05 ± 0.58, and -0.12 ± 0.51 at week 1, week 2, and week 4, respectively (see section 5.2.2, Summary Table 7.1). The mean change from baseline in PIH distribution was -0.03 ± 0.27, -0.06 ± 0.32, and -0.11 ± 0.38 at week 1, week 2, and week 4, respectively (see section 5.2.2, Summary Table 7.2). Subject Global Improvement Scale: The mean ± SD change from baseline in Subject Global Improvement was 1.95 ± 0.82, 2.07 ± 0.82, and 2.28 ± 0.85 at week 1, week 2, and week 4, respectively (see section 5.2.2, Summary Table 8). Patient Preference Results: Subject s Preference Post-Study Questionnaire data will be presented in the final analysis. Safety Results: After 4 weeks of treatment, no treatment-related AE have been noted. One subject was withdrawn from study participation due to the occurrence of non-treatment related adverse events (rash on face). There were no SAEs. Conclusions: Clinically significant reductions in all acne lesion counts at weeks 1, 2 and 4 with the MaxClarity System. MaxClarity was also well tolerated with no treatment-related AEs or SAEs reported by week 4. STIEFEL CONFIDENTIAL Page 6

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 NAME OF SPONSOR/COMPANY: Stiefel, a GSK company NAME OF FINISHED PRODUCT: MaxClarity System: MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) NAME OF ACTIVE INGREDIENT(S): 2.5% benzoyl peroxide, 0.5% salicylic acid INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Not applicable Page: Not applicable (FOR NATIONAL AUTHORITY USE ONLY) Date of the report: 22 May 2012 Signatur Date: MD Consultant Stiefel, a GSK company STIEFEL CONFIDENTIAL Page 7

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 3 TABLE OF CONTENTS 1 TITLE PAGE... 2 2 SYNOPSIS... 3 3 TABLE OF CONTENTS... 8 4 REFERENCE LIST... 9 5 APPENDICES... 10 5.1 Safety Evaluation... 10 5.1.1 Extent of Exposure... 10 5.1.2 Adverse Events... 10 5.1.2.1 Brief Summary of Adverse Events... 10 5.1.2.2 Display of Adverse Events... 10 5.1.2.3 Analysis of Adverse Events... 11 5.1.2.4 Listing of Adverse Events by Subject... 11 5.1.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events... 11 5.1.3.1 Listing of Deaths, Other SAEs, and Other Significant AEs... 11 5.1.3.2 Narratives of Deaths, Other SAEs, and Certain Other Significant AEs... 12 5.1.3.3 Analysis and Discussion of Deaths, Other SAEs, and Other Significant AEs.. 12 5.1.4 Clinical Laboratory Evaluation... 12 5.1.5 Vital Signs, Physical Findings, and Other Observations Related to Safety... 12 5.1.6 Safety Conclusions... 12 5.2 Tables, Figures and Graphs Referred to but not Included in the Text... 13 5.2.1 Subject Disposition and Demographic Data... 13 5.2.2 Efficacy Data... 18 5.2.3 Quality of Life and Patient Preference Data... 32 5.2.4 Safety Data... 34 5.3 Protocol and Protocol Amendments... 44 STIEFEL CONFIDENTIAL Page 8

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 4 REFERENCE LIST No references cited. STIEFEL CONFIDENTIAL Page 9

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5 APPENDICES 5.1 Safety Evaluation 5.1.1 Extent of Exposure A total of 125 subjects consented and were enrolled in this study. For this interim analysis, the mean number of days exposed, the minimum exposure and the maximum exposure are not available. 5.1.2 Adverse Events (AEs) 5.1.2.1 Brief Summary of Adverse Events A total of 11 subjects (8.8%) reported experiencing at least 1 treatment-emergent AE (see section 5.2.4, Summary Table 10.1). Of these, no subject experienced a treatment-related AE. No serious adverse events (SAE) were reported. 5.1.2.2 Display of Adverse Events The most common treatment-emergent AEs were related to the system organ class (SOC) of Infections and Infestations with 10 subjects (35.7%) experiencing such events (see Table 1 below and section 5.2.4, Summary Table 10.1). STIEFEL CONFIDENTIAL Page 10

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 1. Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term (ITT Analysis Set) Total (n = 125) SYSTEM ORGAN CLASS N (%) Preferred Term SUBJECTS REPORTING ANY ADVERSE EVENT 11 (8.8%) GASTROINTESTINAL DISORDERS 1 (0.8%) Gastrooesophageal Reflux Disease 1 (0.8%) IMMUNE SYSTEM DISORDERS 1 (0.8%) Seasonal Allergy 1 (0.8%) INFECTIONS AND INFESTATIONS 6 (4.8%) Nasopharyngitis 3 (2.4%) Oral Herpes 2 (1.6%) Pharyngitis Streptococcal 1 (0.8%) Sinusitis 1 (0.8%) Upper Respiratory Tract Infection 1 (0.8%) Vulvovaginal Mycotic Infection 1 (0.8%) INJURY, POISONING AND PROCEDURAL COMPLICATIONS 1 (0.8%) Contusion 1 (0.8%) NERVOUS SYSTEM DISORDERS 1 (0.8%) Burning Sensation 1 (0.8%) REPRODUCTIVE SYSTEM AND BREAST DISORDERS 1 (0.8%) Ovarian Cyst 1 (0.8%) RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 1 (0.8%) Rhinitis Allergic 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) Rash 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE 5.1.2.3 Analysis of Adverse Events Study products were safe and well tolerated with no treatment-related AE being noted. 5.1.2.4 Listing of Adverse Events by Subject Listings will be provided upon request. 5.1.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events 5.1.3.1 Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events have yet been reported. STIEFEL CONFIDENTIAL Page 11

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.1.3.2 Narratives of Deaths, Other Serious Adverse Events, and Certain Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events have yet been reported. 5.1.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events No deaths, serious adverse events, or other significant adverse events have yet been reported. 5.1.4 Clinical Laboratory Evaluation Clinical laboratory evaluations were not included as part of study procedures, but may be recorded in support of adverse event diagnosis or follow up. 5.1.5 Vital Signs, Physical Findings, and Other Observations Related to Safety Vital signs and physical examinations were not recorded as part of study procedures, but may be recorded in support of adverse event diagnosis or follow up. 5.1.6 Safety Conclusions MaxClarity was well tolerated with no treatment-related AEs or SAEs reported by week 4. STIEFEL CONFIDENTIAL Page 12

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2 Tables, Figures and Graphs Referred to but not Included in the Text 5.2.1 Subject Disposition and Demographic Data Table Number Table 1 Table 2 Table 3 Table 4 Table Title Subject Disposition - ITT Analysis Set Demographics - ITT Analysis Set Baseline Disease Characteristics - ITT Analysis Set Treatment Duration ITT Analysis Set STIEFEL CONFIDENTIAL Page 13

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 1: Subject Disposition ITT Analysis Set This table will be produced for the final statistical analysis. STIEFEL CONFIDENTIAL Page 14

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 2.rtf Program: U0289-405 Table 2.sas Source: Dataset DM Table 2: Demographics ITT Analysis Set Total (n = 125) Age (years) N 125 Mean ± SD 19.0 ± 5.7 Median (P25, P75) 16.9 (15.1, 20.8) Min, Max 12.1, 35.7 Sex, n (%) Male 57 (45.6%) Female 68 (54.4%) Race, n (%) American Indian or Alaskan Native 7 (5.6%) Asian 9 (7.2%) Black 21 (16.8%) Native Hawaiian or Other Pacific Islander 1 (0.8%) White 84 (67.2%) Other 3 (2.4%) Ethnicity, n (%) Hispanic or Latino 27 (21.6%) Not Hispanic or Latino 98 (78.4%) STIEFEL CONFIDENTIAL Page 15

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 3.rtf Program: U0289-405 Table 3.sas Source: Dataset EF_BSL Table 3: Baseline Disease Characteristics ITT Analysis Set Total (n = 125) Investigator Static Global Assessment, n (%) 3- Moderate 84 (67.2%) 4- Severe 41 (32.8%) Inflammatory Lesion Count N 125 Mean ± SD 32.2 ± 6.7 Median (P25, P75) 29.0 (27.0, 37.0) Min, Max 25.0, 50.0 Non-Inflammatory Lesion Count N 125 Mean ± SD 46.5 ± 21.0 Median (P25, P75) 41.0 (28.0, 58.0) Min, Max 21.0, 97.0 Total Lesion Count N 125 Mean ± SD 78.7 ± 24.5 Median (P25, P75) 75.0 (57.0, 92.0) Min, Max 47.0, 146.0 Post-Inflammatory Hyperpigmentation Severity, n (%) 0- Absent 51 (40.8%) 1- Slight 15 (12.0%) 2- Mild 41 (32.8%) 3- Moderate 17 (13.6%) 4- Moderately Severe 1 (0.8%) Post-Inflammatory Hyperpigmentation Distribution, n (%) 0- None 54 (43.2%) 1-1-10% of the face 27 (21.6%) 2-11-20% of the face 32 (25.6%) 3-21-30% of the face 11 (8.8%) 4-31-40% of the face 1 (0.8%) STIEFEL CONFIDENTIAL Page 16

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 4: Study Product Exposure ITT Analysis Set This table will be produced for the final statistical analysis. STIEFEL CONFIDENTIAL Page 17

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.2 Efficacy Data Table Number Table 5.1 Table 5.2 Table 5.3 Table 6 Table 7.1 Table 7.2 Table 8 Table Title Lesion Counts Inflammatory Lesions ITT Analysis Set Lesion Counts Non-Inflammatory Lesions ITT Analysis Set Lesion Counts Total Lesions ITT Analysis Set Investigator Static Global Assessment ITT Analysis Set Post-Inflammatory Hyperpigmentation Assessments Severity ITT Analysis Set Post-Inflammatory Hyperpigmentation Assessments Distribution ITT Analysis Set Subject s Global Improvement Scale ITT Analysis Set STIEFEL CONFIDENTIAL Page 18

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.1: Lesion Counts Inflammatory Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 32.2 ± 6.7 Median (P25, P75) 29.0 (27.0, 37.0) Min, Max 25.0, 50.0 Week 1 N 120 Mean ± SD 22.6 ± 10.0 Median (P25, P75) 22.0 (17.0, 28.5) Min, Max 0.0, 50.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -9.6 ± 8.2 Median (P25, P75) -8.0 (-14.5, -3.0) Min, Max -35.0, 9.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -30.4 ± 25.8 Median (P25, P75) -28.6 (-48.1, -11.4) Min, Max -100.0, 25.7 Missing values 5 Week 2 N 121 Mean ± SD 18.0 ± 10.0 Median (P25, P75) 17.0 (11.0, 23.0) Min, Max 2.0, 52.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -14.3 ± 8.9 Median (P25, P75) -14.0 (-20.0, -8.0) Min, Max -41.0, 12.0 Missing values 4 STIEFEL CONFIDENTIAL Page 19

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.1: Lesion Counts (Continued) Inflammatory Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -44.8 ± 26.4 Median (P25, P75) -44.8 (-64.4, -25.9) Min, Max -93.1, 30.0 Missing values 4 Week 4 N 120 Mean ± SD 15.3 ± 9.8 Median (P25, P75) 14.0 (8.0, 20.0) Min, Max 0.0, 53.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -16.9 ± 9.3 Median (P25, P75) -17.5 (-23.5, -10.0) Min, Max -47.0, 4.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -52.9 ± 27.0 Median (P25, P75) -55.6 (-74.5, -34.3) Min, Max -100.0, 11.4 Missing values 5 STIEFEL CONFIDENTIAL Page 20

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.2: Lesion Counts Non-Inflammatory Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 46.5 ± 21.0 Median (P25, P75) 41.0 (28.0, 58.0) Min, Max 21.0, 97.0 Week 1 N 120 Mean ± SD 39.0 ± 20.2 Median (P25, P75) 32.0 (25.0, 50.0) Min, Max 13.0, 96.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -7.4 ± 12.1 Median (P25, P75) -6.0 (-13.0, 0.0) Min, Max -43.0, 25.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -14.8 ± 24.4 Median (P25, P75) -14.3 (-31.0, 0.0) Min, Max -70.9, 78.6 Missing values 5 Week 2 N 121 Mean ± SD 33.0 ± 19.6 Median (P25, P75) 26.0 (20.0, 41.0) Min, Max 5.0, 94.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -13.4 ± 13.5 Median (P25, P75) -10.0 (-21.0, -5.0) Min, Max -63.0, 18.0 Missing values 4 STIEFEL CONFIDENTIAL Page 21

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.2: Lesion Counts (Continued) Non-Inflammatory Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -28.5 ± 24.4 Median (P25, P75) -27.3 (-44.2, -14.6) Min, Max -89.3, 31.8 Missing values 4 Week 4 N 120 Mean ± SD 29.2 ± 18.7 Median (P25, P75) 24.5 (15.0, 38.0) Min, Max 5.0, 95.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -17.6 ± 15.4 Median (P25, P75) -17.5 (-27.5, -8.5) Min, Max -57.0, 21.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -37.1 ± 30.1 Median (P25, P75) -42.9 (-58.4, -21.5) Min, Max -87.8, 51.2 Missing values 5 STIEFEL CONFIDENTIAL Page 22

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.3: Lesion Counts Total Lesions ITT Analysis Set Total (n = 125) Baseline (Day 1) N 125 Mean ± SD 78.7 ± 24.5 Median (P25, P75) 75.0 (57.0, 92.0) Min, Max 47.0, 146.0 Week 1 N 120 Mean ± SD 61.6 ± 26.8 Median (P25, P75) 54.0 (43.0, 76.0) Min, Max 16.0, 132.0 Missing values 5 Change from Baseline to Week 1 N 120 Mean ± SD -17.0 ± 16.6 Median (P25, P75) -13.5 (-28.0, -5.0) Min, Max -59.0, 25.0 Missing values 5 % Change from Baseline to Week 1 N 120 Mean ± SD -22.2 ± 20.6 Median (P25, P75) -18.5 (-35.9, -7.4) Min, Max -73.8, 28.7 Missing values 5 Week 2 N 121 Mean ± SD 50.9 ± 26.1 Median (P25, P75) 45.0 (32.0, 66.0) Min, Max 7.0, 123.0 Missing values 4 Change from Baseline to Week 2 N 121 Mean ± SD -27.7 ± 18.8 Median (P25, P75) -22.0 (-40.0, -15.0) Min, Max -104.0, 8.0 Missing values 4 STIEFEL CONFIDENTIAL Page 23

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 5.rtf Program: U0289-405 Table 5.sas Source: Datasets EF_BSL & EF_VISITS Table 5.3: Lesion Counts (Continued) Total Lesions ITT Analysis Set Total (n = 125) % Change from Baseline to Week 2 N 121 Mean ± SD -36.0 ± 21.5 Median (P25, P75) -34.5 (-51.5, -21.4) Min, Max -88.4, 9.3 Missing values 4 Week 4 N 120 Mean ± SD 44.4 ± 25.1 Median (P25, P75) 40.0 (25.5, 57.5) Min, Max 8.0, 131.0 Missing values 5 Change from Baseline to Week 4 N 120 Mean ± SD -34.5 ± 20.3 Median (P25, P75) -32.0 (-49.0, -22.5) Min, Max -87.0, 22.0 Missing values 5 % Change from Baseline to Week 4 N 120 Mean ± SD -44.4 ± 23.6 Median (P25, P75) -45.7 (-62.4, -28.5) Min, Max -91.6, 25.6 Missing values 5 STIEFEL CONFIDENTIAL Page 24

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 6.rtf Program: U0289-405 Table 6.sas Source: Datasets EF_BSL & EF_VISITS Table 6: Investigator Static Global Assessment ITT Analysis Set Total (n = 125) Baseline (Day 1), n (%) 3- Moderate 84 (67.2%) 4- Severe 41 (32.8%) Mean ± SD 3.33 ± 0.47 Median (P25, P75) 3.00 (3.00, 4.00) Min, Max 3.00, 4.00 Week 1, n (%) 1- Almost Clear 1 (0.8%) 2- Mild 15 (12.5%) 3- Moderate 83 (69.2%) 4- Severe 21 (17.5%) Mean ± SD 3.03 ± 0.58 Median (P25, P75) 3.00 (3.00, 3.00) Min, Max 1.00, 4.00 Missing values 5 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 1 (0.8%) Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.29 ± 0.51 Median (P25, P75) 0.00 (-1.00, 0.00) Min, Max -2.00, 0.00 Missing values 5 At least one-grade improvement, n (%) 32 (26.7%) At least two-grade improvement, n (%) 3 (2.5%) Week 2, n (%) 1- Almost Clear 2 (1.7%) 2- Mild 27 (22.3%) 3- Moderate 77 (63.6%) 4- Severe 15 (12.4%) Mean ± SD 2.87 ± 0.63 Median (P25, P75) 3.00 (3.00, 3.00) Min, Max 1.00, 4.00 Missing values 4 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 2 (1.7%) STIEFEL CONFIDENTIAL Page 25

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 6.rtf Program: U0289-405 Table 6.sas Source: Datasets EF_BSL & EF_VISITS Table 6: Investigator Static Global Assessment (Continued) ITT Analysis Set Total (n = 125) Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.45 ± 0.61 Median (P25, P75) 0.00 (-1.00, 0.00) Min, Max -2.00, 1.00 Missing values 4 At least one-grade improvement, n (%) 50 (41.3%) At least two-grade improvement, n (%) 6 (5.0%) Week 4, n (%) 1- Almost Clear 4 (3.3%) 2- Mild 40 (33.3%) 3- Moderate 65 (54.2%) 4- Severe 11 (9.2%) Mean ± SD 2.69 ± 0.68 Median (P25, P75) 3.00 (2.00, 3.00) Min, Max 1.00, 4.00 Missing values 5 ISGA of 0 (Clear) or 1 (Almost Clear), n (%) 4 (3.3%) Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.63 ± 0.69 Median (P25, P75) -1.00 (-1.00, 0.00) Min, Max -3.00, 0.00 Missing values 5 At least one-grade improvement, n (%) 63 (52.5%) At least two-grade improvement, n (%) 12 (10.0%) STIEFEL CONFIDENTIAL Page 26

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.1: Post-Inflammatory Hyperpigmentation Assessments Severity ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Baseline (Day 1), n (%) 0- Absent 51 (40.8%) 1- Slight 15 (12.0%) 2- Mild 41 (32.8%) 3- Moderate 17 (13.6%) 4- Moderately Severe 1 (0.8%) Mean ± SD 1.22 ± 1.15 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Week 1, n (%) 0- Absent 47 (39.2%) 1- Slight 18 (15.0%) 2- Mild 40 (33.3%) 3- Moderate 15 (12.5%) Mean ± SD 1.19 ± 1.09 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.03 ± 0.35 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 5 Week 2, n (%) 0- Absent 50 (41.3%) 1- Slight 19 (15.7%) 2- Mild 36 (29.8%) 3- Moderate 16 (13.2%) Mean ± SD 1.15 ± 1.11 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 4 STIEFEL CONFIDENTIAL Page 27

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.1: Post-Inflammatory Hyperpigmentation Assessments (Continued) Severity ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.05 ± 0.58 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 3.00 Missing values 4 Week 4, n (%) 0- Absent 52 (43.3%) 1- Slight 21 (17.5%) 2- Mild 34 (28.3%) 3- Moderate 12 (10.0%) 4- Moderately Severe 1 (0.8%) Mean ± SD 1.08 ± 1.09 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Missing values 5 Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.12 ± 0.51 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 2.00 Missing values 5 STIEFEL CONFIDENTIAL Page 28

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.2: Post-Inflammatory Hyperpigmentation Assessments Distribution ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Baseline (Day 1), n (%) 0- None 54 (43.2%) 1-1-10% of the face 27 (21.6%) 2-11-20% of the face 32 (25.6%) 3-21-30% of the face 11 (8.8%) 4-31-40% of the face 1 (0.8%) Mean ± SD 1.02 ± 1.06 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 4.00 Week 1, n (%) 0- None 51 (42.5%) 1-1-10% of the face 28 (23.3%) 2-11-20% of the face 30 (25.0%) 3-21-30% of the face 11 (9.2%) Mean ± SD 1.01 ± 1.02 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 1, n (%) N 120 Mean ± SD -0.03 ± 0.27 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -1.00, 1.00 Missing values 5 Week 2, n (%) 0- None 55 (45.5%) 1-1-10% of the face 26 (21.5%) 2-11-20% of the face 29 (24.0%) 3-21-30% of the face 11 (9.1%) Mean ± SD 0.97 ± 1.03 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 4 STIEFEL CONFIDENTIAL Page 29

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 7.2: Post-Inflammatory Hyperpigmentation Assessments (Continued) Distribution ITT Analysis Set Output: U0289-405 Table 7.rtf Program: U0289-405 Table 7.sas Source: Datasets EF_BSL & EF_VISITS Total (n = 125) Change from Baseline to Week 2, n (%) N 121 Mean ± SD -0.06 ± 0.32 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -1.00, 1.00 Missing values 4 Week 4, n (%) 0- None 55 (45.8%) 1-1-10% of the face 31 (25.8%) 2-11-20% of the face 24 (20.0%) 3-21-30% of the face 10 (8.3%) Mean ± SD 0.91 ± 1.00 Median (P25, P75) 1.00 (0.00, 2.00) Min, Max 0.00, 3.00 Missing values 5 Change from Baseline to Week 4, n (%) N 120 Mean ± SD -0.11 ± 0.38 Median (P25, P75) 0.00 (0.00, 0.00) Min, Max -2.00, 1.00 Missing values 5 STIEFEL CONFIDENTIAL Page 30

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Output: U0289-405 Table 8.rtf Program: U0289-405 Table 8.sas Source: Dataset EF_VISITS Table 8: Subject's Global Improvement Scale ITT Analysis Set Total (n = 125) Week 1, n (%) 0- Worse 8 (6.7%) 1- Same 15 (12.5%) 2- Mild Improvement 76 (63.3%) 3- Obvious Improvement 17 (14.2%) 4- Marked Improvement 4 (3.3%) Mean ± SD 1.95 ± 0.82 Median (P25, P75) 2.00 (2.00, 2.00) Min, Max 0.00, 4.00 Missing values 5 Week 2, n (%) 0- Worse 3 (2.5%) 1- Same 23 (19.0%) 2- Mild Improvement 61 (50.4%) 3- Obvious Improvement 30 (24.8%) 4- Marked Improvement 4 (3.3%) Mean ± SD 2.07 ± 0.82 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 4 Week 4, n (%) 0- Worse 4 (3.3%) 1- Same 11 (9.2%) 2- Mild Improvement 61 (50.8%) 3- Obvious Improvement 36 (30.0%) 4- Marked Improvement 8 (6.7%) Mean ± SD 2.28 ± 0.85 Median (P25, P75) 2.00 (2.00, 3.00) Min, Max 0.00, 4.00 Missing values 5 STIEFEL CONFIDENTIAL Page 31

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.3 Quality of Life and Patient Preference Data Tables presenting adverse event data are pending full completion of the study. Table Number Table 9 Table Title Subject s Preference Post-Study Questionnaire ITT Analysis Set STIEFEL CONFIDENTIAL Page 32

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 9: Subject s Preference Post-Study Questionnaire ITT Analysis Set This table will be produced for the final statistical analysis. STIEFEL CONFIDENTIAL Page 33

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.2.4 Safety Data Tables presenting adverse event data are pending full completion of the study. Table Number Table 10.1 Table 10.2 Table 10.3 Table 10.4 Table 10.5 Table 10.6 Table 11 Table Title Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Treatment-Emergent Adverse Events Classified by Preferred Term in Descending Order of Frequency ITT Analysis Set Incidence of Treatment-Related Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Severe Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Treatment-Emergent Adverse Events Resulting in Discontinuation Classified by System Organ Class and Preferred Term ITT Analysis Set Incidence of Serious Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Prevalence of Concomitant Medication Use Classified by 2nd ATC level and Preferred Term ITT Analysis Set STIEFEL CONFIDENTIAL Page 34

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.1: Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Total (n = 125) SYSTEM ORGAN CLASS N (%) Preferred Term SUBJECTS REPORTING ANY ADVERSE EVENT 11 (8.8%) GASTROINTESTINAL DISORDERS 1 (0.8%) GASTROOESOPHAGEAL REFLUX DISEASE 1 (0.8%) IMMUNE SYSTEM DISORDERS 1 (0.8%) SEASONAL ALLERGY 1 (0.8%) INFECTIONS AND INFESTATIONS 6 (4.8%) NASOPHARYNGITIS 3 (2.4%) ORAL HERPES 2 (1.6%) PHARYNGITIS STREPTOCOCCAL 1 (0.8%) SINUSITIS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) VULVOVAGINAL MYCOTIC INFECTION 1 (0.8%) INJURY, POISONING AND PROCEDURAL COMPLICATIONS 1 (0.8%) CONTUSION 1 (0.8%) NERVOUS SYSTEM DISORDERS 1 (0.8%) BURNING SENSATION 1 (0.8%) REPRODUCTIVE SYSTEM AND BREAST DISORDERS 1 (0.8%) OVARIAN CYST 1 (0.8%) RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 1 (0.8%) RHINITIS ALLERGIC 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) RASH 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 35

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.2: Incidence of Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term in Descending Order of Frequency ITT Analysis Set Total (n = 125) PREFERRED TERM N (%) SUBJECTS REPORTING ANY ADVERSE EVENT 11 (8.8%) NASOPHARYNGITIS 3 (2.4%) ORAL HERPES 2 (1.6%) BURNING SENSATION 1 (0.8%) CONTUSION 1 (0.8%) GASTROOESOPHAGEAL REFLUX DISEASE 1 (0.8%) OVARIAN CYST 1 (0.8%) PHARYNGITIS STREPTOCOCCAL 1 (0.8%) RASH 1 (0.8%) RHINITIS ALLERGIC 1 (0.8%) SEASONAL ALLERGY 1 (0.8%) SINUSITIS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) VULVOVAGINAL MYCOTIC INFECTION 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 36

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.3: Incidence of Treatment-Related Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set No Treatment-Related Adverse Event was reported during the Study. Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 37

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.4: Incidence of Severe Treatment-Emergent Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set Total (n = 125) SYSTEM ORGAN CLASS N (%) Preferred Term SUBJECTS REPORTING ANY ADVERSE EVENT 1 (0.8%) INFECTIONS AND INFESTATIONS 1 (0.8%) UPPER RESPIRATORY TRACT INFECTION 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 38

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.5: Incidence of Treatment-Emergent Adverse Events Resulting in Discontinuation Classified by System Organ Class and Preferred Term ITT Analysis Set Total (n = 125) SYSTEM ORGAN CLASS N (%) Preferred Term SUBJECTS REPORTING ANY ADVERSE EVENT 1 (0.8%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS 1 (0.8%) RASH 1 (0.8%) Subjects reporting a particular adverse event more than once are counted only once for that adverse event Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 39

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 10.6: Incidence of Serious Adverse Events Classified by System Organ Class and Preferred Term ITT Analysis Set No Serious Adverse Event was reported during the Study. Output: U0289-405 Table 10.rtf Program: U0289-405 Table 10.sas Source: Dataset AE STIEFEL CONFIDENTIAL Page 40

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use Classified by 2nd ATC Level and Preferred Term ITT Analysis Set Total (n = 125) DRUG CLASSIFICATION N (%) Medication ADRENERGICS AND OTH.DRUGS FOR OBSTRUCT.AIRWAY DIS. 1 (0.8%) Seretide 1 (0.8%) AMINOALKYL ETHERS 4 (3.2%) Diphenhydramine 4 (3.2%) ANILIDES 5 (4.0%) Benadryl cold and flu 1 (0.8%) Pamprin 1 (0.8%) Paracetamol 2 (1.6%) Thomapyrin n 1 (0.8%) ANTIALLERGIC AGENTS, EXCL. CORTICOSTEROIDS 1 (0.8%) Olopatadine 1 (0.8%) ANTIINFECTIVES FOR TREATMENT OF ACNE 1 (0.8%) Clindamycin 1 (0.8%) ANTIVIRALS 1 (0.8%) Aciclovir 1 (0.8%) BETA BLOCKING AGENTS, SELECTIVE 2 (1.6%) Metoprolol 2 (1.6%) CALCIUM COMPOUNDS 1 (0.8%) Calcium carbonate 1 (0.8%) CARBAMIDE PRODUCTS 1 (0.8%) Urea 1 (0.8%) CENTRALLY ACTING SYMPATHOMIMETICS 6 (4.8%) Lisdexamfetamine 1 (0.8%) Methylphenidate 3 (2.4%) Obetrol 2 (1.6%) COMB OF PENICILLINS, INCL. BETA-LACTAMASE INHIB. 1 (0.8%) Augmentin 1 (0.8%) COMB.SULFONAMIDES & TRIMETHOPRIM INCL. DERIVATIVES 1 (0.8%) Bactrim 1 (0.8%) CORTICOSTEROIDS 2 (1.6%) Fluticasone 2 (1.6%) CORTICOSTEROIDS, POTENT (GROUP III) 2 (1.6%) Betamethasone 1 (0.8%) Fluocinonide 1 (0.8%) CORTICOSTEROIDS, VERY POTENT (GROUP IV) 1 (0.8%) Clobetasol 1 (0.8%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 41

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use (Continued) Classified by 2nd ATC Level and Preferred Term ITT Analysis Set Total (n = 125) DIPHENYLMETHANE DERIVATIVES 1 (0.8%) Hydroxyzine 1 (0.8%) EXPECTORANTS 1 (0.8%) Guaifenesin 1 (0.8%) GLUCOCORTICOIDS 1 (0.8%) Fluticasone 1 (0.8%) H2-RECEPTOR ANTAGONISTS 1 (0.8%) Famotidine 1 (0.8%) IMIDAZOLE AND TRIAZOLE DERIVATIVES 1 (0.8%) Ketoconazole 1 (0.8%) IMIDAZOLE DERIVATIVES 1 (0.8%) Miconazole 1 (0.8%) INSULINS AND ANALOGUES 1 (0.8%) Insulin 1 (0.8%) INTRAUTERINE CONTRACEPTIVES 2 (1.6%) Intrauterine contraceptive device 2 (1.6%) INTRAVAGINAL CONTRACEPTIVES 10 (8.0%) Intravaginal contraceptives 10 (8.0%) MACROLIDES 1 (0.8%) Azithromycin 1 (0.8%) MULTIVITAMINS WITH MINERALS 1 (0.8%) Multivitamins plus iron 1 (0.8%) MULTIVITAMINS, PLAIN 10 (8.0%) Multivitamin 10 (8.0%) NATURAL OPIUM ALKALOIDS 2 (1.6%) Panadeine co 1 (0.8%) Vicodin 1 (0.8%) OTHER ANTIDEPRESSANTS 2 (1.6%) Trazodone 2 (1.6%) OTHER ANTIEPILEPTICS 1 (0.8%) Lamotrigine 1 (0.8%) Zonisamide 1 (0.8%) OTHER ANTIFUNGALS FOR TOPICAL USE 1 (0.8%) Naftifine 1 (0.8%) OTHER ANTIHISTAMINES FOR SYSTEMIC USE 3 (2.4%) Fexofenadine 2 (1.6%) Loratadine 1 (0.8%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 42

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 Table 11: Prevalence of Concomitant Medication Use (Continued) Classified by 2nd ATC Level and Preferred Term ITT Analysis Set Total (n = 125) OTHER EMOLLIENTS AND PROTECTIVES 2 (1.6%) Dimeticone 1 (0.8%) Other emollients and protectives 1 (0.8%) OTHER LIPID MODIFYING AGENTS 1 (0.8%) Fish oil 1 (0.8%) OTHER NASAL PREPARATIONS 1 (0.8%) Sodium chloride 1 (0.8%) OTHER PLAIN VITAMIN PREPARATIONS 1 (0.8%) Biotin 1 (0.8%) OXICAMS 1 (0.8%) Meloxicam 1 (0.8%) PENICILLINS WITH EXTENDED SPECTRUM 1 (0.8%) Amoxicillin 1 (0.8%) PIPERAZINE DERIVATIVES 6 (4.8%) Cetirizine 6 (4.8%) PREPARATIONS CONTAINING SULFUR 1 (0.8%) Rosula 1 (0.8%) PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS 9 (7.2%) Anovlar 2 (1.6%) Cilest 4 (3.2%) Drospirenone w/ethinylestradiol 1 (0.8%) Eugynon 1 (0.8%) Norlestrin fe 1 (0.8%) PROPIONIC ACID DERIVATIVES 6 (4.8%) Ibuprofen 5 (4.0%) Naproxen 1 (0.8%) SELECTIVE BETA-2-ADRENORECEPTOR AGONISTS 4 (3.2%) Salbutamol 4 (3.2%) SELECTIVE SEROTONIN REUPTAKE INHIBITORS 4 (3.2%) Citalopram 2 (1.6%) Fluoxetine 1 (0.8%) Paroxetine 1 (0.8%) SYMPATHOMIMETICS 1 (0.8%) Pseudoephedrine 1 (0.8%) UNSPECIFIED HERBAL 2 (1.6%) Herbal preparation 2 (1.6%) Subjects reporting a particular concomitant medication more than once are counted only once for that drug Output: U0289-405 Table 11.rtf Program: U0289-405 Table 11.sas Source: Dataset CM STIEFEL CONFIDENTIAL Page 43

Stiefel, a GSK company MaxClarity Clinical Study Report U0289-405 5.3 Protocol and Protocol Amendments STIEFEL CONFIDENTIAL Page 44

Stiefel, a GSK company Clinical Study Protocol U0289-405, Version 1.0 An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the MaxClarity System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne Clinical Study Protocol: U0289-405 (STF115576) Version 1.0: 17 March 2011 Sponsored by: Stiefel, a GSK company 20 TW Alexander Drive Research Triangle Park, NC 27709 THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR STIEFEL OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF STIEFEL. STIEFEL CONFIDENTIAL 1