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1 Clinical Trial Details (PDF Generation Date :- Tue, 02 Oct :40:33 GMT) CTRI Nuber Last Modified On 24/02/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/04/ [Registered on: 21/04/2011] - Trial Registered Prospectively No Interventional Drug Randoized, Parallel Group Trial A Clinical trial intended to copare Clindaycin & Benzoyl Peroxide cobination topical gel to Duac of Stiefel Labs, in patients with ild to oderate acne vulgaris. A Randoized, Double-blind, Multi-center, Parallel-group, Pilot clinical study to copare the efficacy and evaluate safety of Clindaycin 1% / Benzoyl Peroxide 5% Topical Gel (Cadila Healthcare Liited, ) with Duac Topical Gel (Stiefel Laboratories, USA) in Patients with Acne Vulgaris. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CRL/CT/02/10-11 Designation Affiliation Protocol Nuber Details of Principal Investigator Dr Ranjan Rawal Head Of Departent Phone Fax Eail Designation Affiliation Dept of Deratology, V.S. Hospital, Skin OPD, 1st Floor, Ellis Bridge, ranjancraval@gail.co Details Contact Person (Scientific Query) Dr Charu Gauta Director Clinical Operations Phone Fax Eail Designation Affiliation BA Research Liited Opp. Pushparaj Towers, Bodakdev, charu@baresearchindia.co Details Contact Person (Public Query) Mr Chirag Shah Head Clinical Trials BA Research Liited Opp. Pushparaj Towers, Bodakdev, page 1 / 6

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Phone Fax Eail Source of Monetary or Material Support > Cadila Healthcare Liited Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist: , Gujarat,. Tel# Fax# Type of Sponsor BA Research Liited List of Countries of Principal Investigator Dr Bela Shah Dr Chitra Nayak Priary Sponsor Details Cadila Healthcare Liited Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist: , Gujarat,. Pharaceutical industry-n BA Research Liited Opp. Pushparaj Towers, Bodakdev, Gujarat, of Site Site Phone/Fax/Eail BJ Medical College, Civil Hospital BYL Niar Hospital and TN edical college Dept of Deratology, ST and Leprosy, Roo-139, 1st floor, OPD Building, BJ Medical College, Civil Hospital, Asarwa, Dept of Deratology, OPD No 14, BYL Niar Hospital and TN edical college, Dr AL Nair Rd, Central, Dr Prachi Matte Dera Lesar Clinic Dera Lesar Clinic, B-Wing, 8th Floor, Lokat Building, Radaspeth, Nagpur Nagpur Dr Vikrant Saoji Dr. Saojis Clinic Dr Saojis Clinic, Navprabhat Chaber, Opp Tarun Bharat, Central Bazaar Road, 27, Radaspeth, Nagpur Nagpur shah.drbela@gail.co chitra1202@yahoo.co.i n dr.prachiatte@sify.co vikrantsaoji@hotail.co Dr D G Saple Dr. Saples Clinic Dr Saples Clinic, page 2 / 6

3 Details of Ethics Coittee Dr B Leelavathy Dr A S Kuar Dr Deepa Bhatt Dr Sandesh Gupta Dr Ranjan Rawal MS Diabetes and Shirdi Skin Care Centre Owaisi Hospital & Research Center SCL Muncipal Hospital, Skin & Laser Centre, Delhi V.S. Hospital, Hindu Colony, 3rd Lane, Near Bhagini Saaj, Dadar, MS Diabetes and Shirdi Skin Care Centre, No 6/1, Opp Hotel Krishnasagar, 80 ft Road, Indiranagar, Bangalore Bangalore KARNATAKA Dept of Deratology, Owaisi Hospital & Research Center, Kanchan Baug, Hyderabad Hyderabad ANDHRA PRADESH clinic@drsaple.co drleelaskincare@gail. co dr_askuar@yahoo.co. in Dept of Deratology, SCL Muncipal Hospital, Saraspur, - deepabhatt_ahd@yaho o.co Skin & Laser Centre, F-12/10, Krishna Nagar, Delhi drsandeshg@rediffail. North East co DELHI Dept of Deratology, V.S. Hospital, Skin OPD, 1st Floor,Ellis Bridge, ranjancraval@gail.co of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? Clinical Ethics Foru, Approved 25/02/2011 Yes CLINICOM, Bangalore Approved 17/02/2011 Yes IEC- Nagpur Approved 31/01/2011 Yes Independent Ethics Coittee, Nagpur Independent Ethics Coittee-Clinico Institutional Ethics Coittee, Institutional Ethics Coittee, Hyderabad Nair Golden Jubilee Research Foundation, Approved 31/01/2011 Yes Approved 17/02/2011 Yes Approved 07/04/2011 No Approved 26/02/2011 No Approved 09/04/2011 No page 3 / 6

4 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Intervention / Coparator Agent Inclusion Criteria NHL-IEC, Approved 22/02/2011 No Rogi Kalyan Saiti, Status Approved 28/02/2011 No Date Approved/Obtained 30/03/2011 Health Type Patients Condition Mild to Moderate Acne Vulgaris Type Details Coparator Agent Intervention Age Fro Age To Gender Duac Topical Gel (Stiefel Laboratories, USA)Clindaycin 1% + Benzoyl Peroxide 5% Topical Gel Clindaycin 1% / Benzoyl Peroxide 5% Topical Gel (Cadila Healthcare Liited, ) Year(s) Year(s) Both Inclusion Criteria Once Daily on the affected area for 11 Weeks Once Daily on the affected area for 11 Weeks Details 1. Be Healthy ale or non-pregnant non-lactating feale subjects 13 to 40 years of age; 2. Be able to provide signed infored consent. Subjects of 18 years or older ust provide IEC/IRB approved written infored consent. Subjects of less than 18 years age ust have IEC/IRB approved written infored consent fro a parent or legal guardian. Subjects of 13 C 17 years age ust coplete an IEC/IRB approved assent for for inors. 3. Have clinical diagnosis of Acne Vulgaris and on the face, 25 non- inflaatory lesions (i.e. open and closed coedones) AND 0 inflaatory lesions (i.e. papules and pustules) AND 2 nodulocystic lesions (i.e. nodules and cysts). 4. Local Tolerance grading 0, 1 or Investigators Global Evaluation (IGE) of acne severity grade 2 or Willing to refrain fro use of all other topical acne edications or antibiotics during the 11 week treatent period. 7. All subjects will be evaluated by the principal or sub-investigator physician during a pre-study edical evaluation perfored within 15 days of the initial dose of study edication which will include: 8. a noral or non-clinically significant physical exaination, including vital signs (blood pressure, heart rate, respiratory rate and teperature); 9. within noral liits or non-clinically significant laboratory evaluation results for the clinical laboratory tests. 10. Willing and able to understand the requireents of the study, abide by the restrictions, apply the edication as instructed, and return for the required study visits. 11. Be in good health and free fro any clinically significant disease, other than acne vulgaris, that ight interfere with the study evaluations. 12. Have used the sae brand of ake-up for a iniu period of 2 weeks prior to randoization, for subjects who use ake-up, and agree to not change ake-up brands or types during the study. Exclusion Criteria Exclusion Criteria page 4 / 6

5 Details 1. Be pregnant or breast feeding. 2. Have presence of any skin condition that would interfere with the diagnosis or assessent of acne vulgaris; which includes, on the face: 2 nodulocystic lesions, rococo, deratitis, psoriasis, squaous cell carcinoa, eczea, acnefor eruptions caused by edications, steroid acne, steroid folliculitis, or bacterial folliculitis. 3. Excessive facial hair (e.g. beards, sideburns, oustaches, etc) that would interfere with the diagnosis or assessent of acne vulgaris 4. Have a history of hypersensitivity to clindaycin, lincoycin, benzoyl peroxide, or any coponent of the study edication forulations. 5. Use within 6 onths prior to randoization of oral retinoids or therapeutic Vitain A suppleents of greater than 10,000 units/day 6. Have received treatent with systeic antibiotics or steroids within 4 weeks of study start or topical antibiotics or steroids within 2 weeks of study start 7. Use on the face within one onth prior to randoization or during the study of: a) cryodestruction or cheodestruction, b) derabrasion, c) photodynaic therapy, d) acne surgery, e) intra lesional steroids, f) x-ray therapy 8. Use within one onth prior to randoization of, a) spironolactone, b) systeic steroids, c) systeic antibiotics, d) systeic treatent for acne vulgaris or e) Systeic Anti inflaatory agents. 9. Have received treatent with topical anti-acne edications within the 2 weeks prior to the study (topical steroids, topical retinoids, topical acne treatents including over the counter preparations, topical anti inflaatory agents, edicated cleansers or topical antibiotics 10. Have any systeic or deratologic disease that ay effect the evaluation of study results. 11. Have a history of regional enteritis, ulcerative colitis, pseudoebranous colitis or antibiotic-associated colitis. 12. Subjects with clinically significant unstable edical disorders, life-threatening disease, or current alignancies. 13. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight. 14. Subjects who consue excessive aounts of alcohol (ore than 3-4 drinks per day), abuse drugs, or have any condition that would coproise copliance with this protocol. 15. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry Method of Generating Rando Sequence Method of Concealent Blinding/Masking Other Other Participant, Investigator and Outcoe Assessor Blinded Priary Outcoe Outcoe Tiepoints Mean percent reduction fro baseline to Day 77 in the nuber of inflaatory acne lesions Mean percent reduction fro baseline to Day 77 in the nuber of inflaatory acne lesions Secondary Outcoe Outcoe Tiepoints Target Saple Size ean percent change in no. of non-inflaatory lesions, ean percent change in no. of total lesion count and change in Investigator Assessent Total Saple Size=60 Saple Size fro =60 Fro Baseline to End of Study Visit page 5 / 6

6 Powered by TCPDF ( PDF of Trial Phase of Trial Phase 3/ Phase 4 Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary 25/04/2011 No Date Specified Years=0 Months=2 Days=0 Not Applicable Copleted Not Applicable presently A Randoized, Double-blind, Multi-center, Parallel-group, Pilot clinical study to copare the efficacy and evaluate safety of Clindaycin 1% / Benzoyl Peroxide 5% Topical Gel (Cadila Healthcare Liited, ) with Duac Topical Gel (Stiefel Laboratories, USA) in Patients with Acne Vulgaris. The study duration is of 60 days and will be conducted in 10 study centers in. The priary efficacy easures are (1) Mean percent reduction fro baseline to Day 77 in the nuber of inflaatory acne lesions, and (2) ean percent change in no. of non-inflaatory lesions, (3) ean percent change in no. of total lesion count page 6 / 6