Client: NATURA LABORATORIJI D. O. O. POD JELŠAMI 12 1290 GROSUPLJE SLOVENIJA Sample (according to declaration of the Client) 1. TESTED PRODUCT: HAIR INHIBITOR 2. COMPARATIVE PRODUCT: INHIBITIF Received on: 06.04.2018 Analysis completed on: 23.05.2018 Report date: 30.05.2018 REPORT OF INSTRUMENTAL TEST AFTER 30 DAYS OF PRODUCT APPLICATION Page 1 / 19
CONTENT OF THE REPORT 1. THE BASIS TO CONDUCT THE STUDY... 3 2. SUBJECT OF THE TEST... 4 2.1 Description of the product... 4 2.2 Qualitative composition of the product (INCI)... 4 3. AIM OF THE STUDY... 5 3.1 Study duration... 5 3.2 Testing methodology... 5 3.2.1 Instrumental test... 5 3.2.1.1 Measurement of hair density before and after the products application using Aramo SG ASG 200F... 5 3.2.1.2 Photographic documentation... 5 4. DESCRIPTION OF SUBJECTS... 6 5. RESULTS... 7 5.1 Characteristic of subjects... 7 5.2 The instrumental test result... 8 5.2.1 Measurement of hair density before and after the products application using Aramo SG ASG 200F... 8 5.2.2 Photographic documentation... 10 6. CONCLUSION... 17 7. APPENDIXES... 18 7.1 Randomization list... 18 8. SIGNATURES... 19 Page 2 / 19
1. THE BASIS TO CONDUCT THE STUDY TESTED PRODUCT: HAIR INHIBITOR Samples delivered by the Customer. The qualitative composition of the product delivered by the Customer. Statement that product is microbiologically low risk cosmetic. Negative result of occlusive patch test delivered by the Customer. COMPARATIVE PRODUCT: INHIBITIF Samples delivered by the Customer. The qualitative composition of the product delivered by the Customer. Statement that product is being sold globally for years. The Customer is responsible for conformity with the declared quality composition of the product and negative result of dermatological test of the delivered samples. SCOPE OF TESTS COMPLIANT WITH: Regulation of the European Parliament and of the Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products. Cosmetics Europe The Personal Care Association (previously COLIPA) Guidelines "Product Test Guidelines for the Assessment of Human Skin Compatibility 1997." Cosmetics Europe The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008. Technical Instruction exercised at the J.S. Hamilton Poland S.A. IT-01/PK. Technical Instruction exercised at the J.S. Hamilton Poland S.A. IT-03/PK. Technical Instruction exercised at the J.S. Hamilton Poland S.A. IT-14/PK. Technical Instruction exercised at the J.S. Hamilton Poland S.A. IT-16/PK. Technical Instruction exercised at the J.S. Hamilton Poland S.A. IT-43/PK. Page 3 / 19
2. SUBJECT OF THE TEST 2.1 Description of the product REPORT No. 146515/18/CGDA/1 Parameter Fragrance Intended use Direction of use Description Characteristic for used raw materials The product is intended for use as a hair growth inhibitor Subject use both products: TESTED PRODUCT: HAIR INHIBITOR on one leg and COMPARATIVE PRODUCT: INHIBITIF on another leg, according to randomization list. The subject can not mix the products and sides, not applying with the same hand both products without washing. The products were used twice daily. Product photo 2.2 Qualitative composition of the product (INCI) TESTED PRODUCT: HAIR INHIBITOR CAPRIC TRYGLICERIDE, PARAFFINUM LIQUIDUM, LAURYL ISOQUINOLINIUM BROMIDE, POLYURETHANE, AQUA. COMPARATIVE PRODUCT: INHIBITIF WATER (AQUA), PROPANEDIOL, BUTYLENE GLYCOL, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, LAURYL ISOQUINOLINIUM BROMIDE, PSEUDOALTEROMONAS FERMENT EXTRACT, DIHYDROMYRICETIN, POLYQUATERNIUM-37, DISODIUM EDTA, ISOPROPYL ALCOHOL, ALLANTOIN, CAPRYLYL BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, PPG-26-BUTETH-26, PHENOXYETHANOL, CHLORPHENESIN, FRAGRANCE, LINALOOL, D-LIMONENE. Page 4 / 19
3. AIM OF THE STUDY Confirmation/exclusion of the declared properties and efficiency of the product. 3.1 Study duration 30 days (23.04.2018 23.05.2018) 3.2 Testing methodology 3.2.1 Instrumental test The characteristics of the panel and numbers of subjects (10 people) were in line with Customer requirements (in accordance with Study Program No. 225.1.18.Z4). 3.2.1.1 Measurement of hair density before and after the products application using Aramo SG ASG 200F The aim of the study is to measure hair density before and after the product application. The test has been conducted using special measuring device manufactured by ARAM HUVIS Co., Ltd. ARAMO SG ASG 200F. Instrumental study has been carried out on 10 subjects. The measurements in zoom 60-times has been performed at the site of application before product application (D0) and after 30 days (D30) of regular use. All measurements have been carried out in an air conditioned room in the temp. of 20±2ºC and relative humidity 50±10%. The products efficacy is confirmed in case of the positive results obtained in more than 50% of subjects. 3.2.1.2 Photographic documentation The photos are documenting the reduction in the amount of hair. The photos have been taken at the site of application before product application (D0) and after 30 days (D30) of regular use. The study has been carried out on 10 subjects. Page 5 / 19
4. DESCRIPTION OF SUBJECTS Inclusion criteria: Sign an informed consent to participate in the study, were informed about the purpose of the study, the manner of its conduct and the GENERAL possible side effects. The site of application without irritation and changes requiring pharmacological treatment (specialist evaluation). Amount of subjects: 10 subjects SPECIFIC Gender: Women Age: 18+ Skin type: All Page 6 / 19
Subject's code 5. RESULTS 5.1 Characteristic of subjects Gender Age Study initiation date Visit after 30 days 1. DK W 47 23.04.2018 23.05.2018 2. EW W 37 23.04.2018 23.05.2018 3. AL W 46 23.04.2018 23.05.2018 4. JRM W 41 23.04.2018 23.05.2018 5. HW W 27 23.04.2018 23.05.2018 6. MM W 34 23.04.2018 23.05.2018 7. JK W 39 23.04.2018 23.05.2018 8. MS W 22 23.04.2018 23.05.2018 9. DW W 23 23.04.2018 23.05.2018 10. AJ W 34 23.04.2018 23.05.2018 WO MEN (W) 10 THE A V ERA GE A GE 35 NUMBER O F SUBJEC TS, WHO STA RTED THE INSTRUMENTA L TEST NUMBER O F SUBJEC TS, 10 WHO ENDED THE 10 INSTRUMENTA L TEST MINIMA L A GE 22 MA XIMUM A GE 47 Page 7 / 19
5.2 The instrumental test result. 5.2.1 Measurement of hair density before and after the products application using Aramo SG ASG 200F Assumption: The product efficiency is confirmed, when the parameter value decreases. TESTED PRODUCT: HAIR INHIBITOR Table 1. Aramo SG ASG 200F. The mean results of hair density at the site of the product application on measurements before application (D0) and after 30 days (D30) of regular use in [average amount of hair/cm 2 ]. Subject s code First measurement (D0) Measurement after 30 days (D30) Difference (D30-D0) 1.DK EXCLUDED EXCLUDED EXCLUDED 2.EW 15 13-2 3.AL 17 13-4 4.JRM 15 12-3 5.HW 10 8-2 6.MM 13 15 2 7.JK 13 12-1 8.MS 15 13-2 9.DW 12 5-7 10.AJ 20 17-3 Mean 14,4 12,0-2,4 Min 10,0 5,0-7,0 Max 20,0 17,0 2,0 SD 2,9 3,6 2,3 Median 15,0 13-2,0 Δ% -17% % of subjects with the positive effect 89% Conclusion: The product TESTED PRODUCT: HAIR INHIBITOR reduces hair density, and thus decreases the amount of hair. Page 8 / 19
COMPARATIVE PRODUCT: INHIBITIF REPORT No. 146515/18/CGDA/1 Table 2. Aramo SG ASG 200F. The mean results of hair density at the site of the product application on measurements before application (D0) and after 30 days (D30) of regular use in [average amount of hair/cm 2 ]. Subject s code First measurement (D0) Measurement after 30 days (D30) Difference (D30-D0) 1.DK EXCLUDED EXCLUDED EXCLUDED 2.EW 13 12-1 3.AL 15 19 4 4.JRM 12 12 0 5.HW 12 10-2 6.MM 13 17 4 7.JK 12 10-2 8.MS 15 10-5 9.DW 15 8-7 10.AJ 15 15 0 Mean 13,6 12,6-2,0 Min 12,0 8,0-4,0 Max 15,0 19,0 4,0 SD 1,4 3,7 3,6 Median 13,0 12,0-1 Δ% -7% % of subjects with the positive effect 56% Conclusion: The product COMPARATIVE PRODUCT: INHIBITIF reduces hair density, thus decreases the amount of hair. Page 9 / 19
5.2.2 Photographic documentation Assumption: Product s properties are confirmed, when amount of hair decreases. TESTED PRODUCT: HAIR INHIBITOR Table 3. The images at the site of application before (D0) and after 30 days (D30) of regular use. Subject s code Before (D0) After 30 days (D30) 1.DK 2.EW Page 10 / 19
3.AL 4.JRM 5.HW Page 11 / 19
6.MM 7.JK 8.MS 9.DW Page 12 / 19
10.AJ Conclusion: The decreased in the amount of hair was observed in 9 out of 10 subjects. Page 13 / 19
COMPARATIVE PRODUCT: INHIBITIF REPORT No. 146515/18/CGDA/1 Table 4. The images at the site of product application before (D0) and after 30 days (D30) of regular use. Subject s code Before (D0) After 30 days (D30) 1.DK 2.EW 3.AL Page 14 / 19
4.JRM 5.HW 6.MM 7.JK Page 15 / 19
8.MS 9.DW 10.AJ Conclusion: The decreased in the amount of hair was observed in 6 out of 10 subjects. Page 16 / 19
6. CONCLUSION Under these study conditions, after 30 days of regular application, the product: TESTED PRODUCT: HAIR INHIBITOR reduces hair density, thus decreases the amount of hair (average 17%). COMPARATIVE PRODUCT: INHIBITIF reduces hair density, thus decreases the amount of hair (average 7%). Page 17 / 19
7. APPENDIXES 7.1 Randomization list Subject's code TESTED PRODUCT: HAIR INHIBITOR COMPARATIVE PRODUCT: INHIBITIF 1.DK RIGHT LEG LEFT LEG 2.EW RIGHT LEG LEFT LEG 3.AL RIGHT LEG LEFT LEG 4.JRM RIGHT LEG LEFT LEG 5.HW RIGHT LEG LEFT LEG 6.MM LEFT LEG RIGHT LEG 7.JK LEFT LEG RIGHT LEG 8.MS LEFT LEG RIGHT LEG 9.DW LEFT LEG RIGHT LEG 10.AJ LEFT LEG RIGHT LEG Page 18 / 19
8. SIGNATURES Authorized by: Katarzyna Cięszczyk Project Manager Senior Assistant Study design Supervision ROK DEVJAK MD PhD Natura laboratoriji d.o.o.
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