Sie sind auf Seite 1von 25
CONFIDENTIAL REPORT Réf : EC-MX01-BC-MS01 EVALUATION OF THE EFFICACY OF A HAIR GROWTH ACCELERATION TREATMENT : HAIR GROWTH KINETICS MEASUREMENT 1 SELF-EVALUATION QUESTIONNAIRES. REFERENCES OF THE TEST PRODUCTS : Shampoo : 304 170 Accelerator Conditionner : $09 180 BRAND PRODUCTS : Hair jazz In vivo test on subjects ‘Study Sponsor: Bac BP 6i7 59061 ROUBAIX Cedex 01 B2Crant wsTt™ SDNIX rue de saan a ee as wet ease SPINCONTROL Suillet 2001 238, rue Giraudeau 37000 TOURS i EC- MXO1-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 ~ Conditioner $09180 Confidential Document CONTENTS 1. TRIAL CONDITIONS, nn La Site of experimentation, ee 2 12. ‘Study Sponsor. : a 2 13. Study Monitor rn . 2 La Investigator, 2 Is. Scientific : 2 te Technician . —— a 2 uw. Quality Assurance Manager : 2 2. STUDY SUMMARY. _ a co a) 24 Objectives, 22, Study Popuiation 23, ‘Trial period, kinetics, and schedule. 24, Study Design, . 3. METHODOLOGY, nse 31 Subject SeleCtiOR eres 4 BLL The inclusion, exchision and resiricions criteria defined in the protocol are listed below. 4 32. Non-inclusion criteria, 5 B13. Proscriptions and restrictions, 7 5 32, Product Presentation... — ~ 5 32 Product Application ~ Frequency ~ Methods. 6 322 Tolerance. a s 33, Choice of ta. 6 34 Randomisation EEE 7 35. ‘Assessment methods : 7 35 Growth kinetics measurement. 7 352. Self-evaluation Questionnaires i 7 36 Examination schedule. “8 37. Presentation of results ae eS 9 B21 Global results for the panel as @ whole... vss 9 372 Individual results... an 373 Stasis 7 : : 9 4. ETHICAL AND LEGAL CONSIDERATIONS, rn 4 Study Personnel, 42. “Archiving ofthe data. 43, Tnsurance Ln 44 Declaration tothe GNI 45, Anonymity ofthe subjecis 46. ‘Consent to participate inthe sul 47 Confidentiality . oo 48, Quality of Assurance, — ” 49, ‘Annex documents not diecily related to the sadly, 5. RESULTS, . . . nn . 2 Su ‘Compliance with the protocol, . 82 Hair growth kinetics measurement results. eS 521. Global results (Annes 1) : . 522. Interpreted results (Annex 3). 53. Self-evaluation results (Annex 3), - 5a ConehS HOR enn : : ANNEX 1: GLOBAL RESULTS ~ GROWTH KINETICS MEASUREMENTS ANNEX 2: INTERPRETED RESULTS — GROWTH KINETICS MEASUREMENTS ANNEX 3: RESULTS ~ SELF-EVALUATION ANNEX 4: COPY OF THE PROTOCOLE (French Version) ANNEX 5: CERTIFICATIONS AND ATTESTATIONS Spincontrol-B2C EC- MXO1-BC-MSO1-EC-RA-VO1) Products: Shampoo 304 170 — Conditioner $09180 Confidential Document 1. TRIAL CONDITIONS Ll. 12. 13. 14. 15. 1.6. 17. Spincontrol.B2C Site of Experimentation SPINCONTROL 238 rue Gireaudau — F-37000 TOURS — FRANCE Tel: +33 (0)2 47 37 62 79 Fax: +33 (0)2 47 37 58 28 e-mail: spincontrol@spincontrol fe Study Sponsor B2C BP 617 F-59061 ROUBAIX Cedex 01 — FRANCE, Study Monitor S.CATRYSSE B2C BP 617 F-59061 ROUBAIX Cedex 01 - FRANCE, Tel: +33 (0)3 20 26 27 28 Fax: +33 (0)3 20 26 27 48 Investigator P.BEAU, Ph.D Manager SPINCONTROL Scientific Manager & Study Director JCPITTET, Ph.D SPINCONTROL Tel: +33 (0)2 47 37 12 86 e-mail: pittet@spincontrol ft Technician S.JACOB SPINCONTROL Quality Assurance Manager CPERRIER SPINCONTROL Tel: #33 (0)2 47 37 09 49 EC- MX01-DC-MS01-EC-RA(V01) Products: Shampoo 304 170 — Conditioner 509180 ‘Confidential Document 2. STUDY SUMMARY 2. Objectives The objective of this trial was to assess the efficacy of a hair growth accelerator treatment. This treatment was composed of a treatment shampoo and a conditioner identified under the reference numbers listed below: Shampoo Ref.: 304 170 Conditioner Ref.: 509180 This assessment was performed using: * Self-evaluation questionnaires answered by the test subjects; * An analysis of the hair grown rate. ‘The assessment was undertaken over a total period of 28 days of treatment application. 2.2. Study Population ‘The test was carried out on 60 healthy subjects. The individuals recruited for this study were all women, These subjects had to strictly meet the inclusion/exclusion criteria listed in paragraph 3.1.1 The 60 subjects were divided into two distinct group: Group 1: 30 subjects who applied no hair treatment at all (Control Group) Group 2: 30 subjects who applied the two products daily (Treated group) Their average age and hair type (oily and dry) were equally represented within the 2 groups. 2.3, Trial period, kinetics, and schedule The trials began on April 17 and 18, 2001, and were concluded on May 15 and 16, 2001. Study kinetics: To 728 days | | > 17 & 18 April, 2001 15 & 16 May, 2001 - Hair bleaching - Hair sampling ~ Self-evaluation - questionnaire 2.4, Study Design = This study was an “open” study. - It was a comparative study, ie. the effects of the treatment observed on Group2 ({reated) were compared to the natural variations observed on Control Group 1. = The subjects did not serve as their own control reference. Spincontrol-B2C EC- MX01-BC-MSO1-EC-RA-(VO1) Products: Shampoo 304 170 — Conditioner 509180, Confidential Document 3. METHODOLOGIE 3.1. Subjects Selection SPINCONTROL’s test panel was made up of subjects who had answered a computer questionnaire prior to selection about their medical history, allergies, skin care and cosmetics habits, as well as various administrative details. The enrolments were undertaken by a licenced beautician, The procedure used to recruit, select, and include the subjects, who freely gave their fully- informed consent to participate in this study, was drawn up to ensure clear and precise information enabling the latter to appreciate the object and consequence of their consent. This procedure includes in particular: - A preliminary interview held to explain the study objective and protocol, the study schedule and, as the case may be, the forms of compensation, as well as any possible cosmetics benefits to be expected, the constraints and potential risks linked to the study; - The reading of a data sheet that stipulates the essential features of the study to enable the subjects to freely decide whether to participate or not based on the proposed conditions, and then sign this forms giving their express, informed consent; - This consent makes it possible include the subject for coverage by the civil liability insurance policies taken out independently by the study Sponsor and Investigator as soon as the subjects has been definitively admitted to participate in the study by its coordinator. The subjects recruited for the study were selected under the responsibility of the study investigator and coordinator based on the inclusion/exclusion and proscription/restriction criteria listed in this protocol. There were 60 subjects recruited for this study. The results presented cover the totality of the subjects on hand for the final assessment day (128 days). 3.1.1. The inclusion, exclusion and restrictions criteria defined in the protocol are listed below General: «© Healthy subjects; «Available for the entire duration of the study; Motivated to freely participate in the study; Not simultaneously engaged in any other testing with or without a direct therapeutic effect; © Having no remaining effects from a prior cosmetic, dermatological or medical study at the beginning of the study involving the scalp or hair, ‘* Not having modified their cosmetic habits (skin-care products, cleansers, etc.) in at least the past 15 days; ‘© Able to justify having a permanent address; Able to understand the French language: i.c., French-speaking subjects capable of reading and understanding the study documents and able to follow the explanations given; * Having the benefit of social security medical coverage. Specific to the study © Female; © Caucasian; Spincontrol-B2C EC- MXO1-BC-MSO1-EC-RAV01) Products: Shampoo 304 170 - Conditioner 509180 ‘Confidential Document Between 18 and 40 years of age; With oily or dry hair (30 of each in the two 2 groups); With mid-length hair of a dark shade (chestnut, brown to black); With healthy skin (free of psoriasis, eczema, erythema, edema, scars, or cancerous legions) and particularly on the scalp; Neither pregnant nor nursing a baby for a last the past 3 months; Not having changed their contraception methods in the past three months and agreeing to continue their present method for the duration of the study; Having a regular cycle or taking an oral contraceptive; Taking no hormonal treatments linked to a health condition (e.g., thyroid problems, etc); Having no skin hypersensitivity or allergy to cosmetics, and particularly to hair bleaching products; + Not suffering from atopic skin; «Not having undertaken any type of weight-loss diet for at last the past three months and. not planning to do so during the study; * Accepting not to undertaken any UV sessions in an institute for the entire duration of the study; * Accepting not to dry their hair with a hair dryer; * Accepting not to colour or bleach their hair for the duration of the study. 3.1.2, Non-inelusion criteria * Lacking any inclusion criteria listed above; «Having failed to heed the provision of article L 209-17 of the modified law dated 20/12/88 pertaining to: © The prohibition of taking part simultaneously in several biomedical studies without direct individual benefit; © The period of “non inclusion” during which an individual may not take part in any: other biomedical study without direct individual benefit. © Being deprived of liberty due to a legal or administrative decision, suffering from illness. and in need of emergency care (article 1209-5); © Being a minor or of age but under legal guardianship or institutional care, insofar as the study can be undertaken in a different manner (article 1209-6). © Failing to acquiesce by refusing to sign the express, informed consent form. 3.1.3 Proscriptions and Restrictions Application of any other cosmetic product that tints, bleaches, or treats hair is proscribed; Use of another shampoo beside the one provided for the group applying the treatment is proscribed. (The subjects in the control group can use their usual product, without switching to another, for the duration of the study); © The subjects selected must under no circumstances have their hair cut during the entire study. 3.2, Product Presentation The products under study were provided by the study sponsor. The products (shampoo and conditioner were packaged in 250 ml bottles). The sponsor was responsible for manufacturing, packaging, identifying, and monitoring the purity, composition, innocuousness, and other characteristics of the products being tested. ‘The sponsor agreed to furnish a certificate confirming the absence of any toxicity in the products being tested. Spincontrol-B2C EC- MX01-BCMSO1-EC-RA-(V01) Produets: Shampoo 304 170 ~ Conditioner 509180 Confidential Document Shampoo Ref.: 304 170 Conditioner Ref.: 509180 For the purpose of this study, the sponsor provided + The number of products necessary for the subjects participating in the study; * Enough product for the additional subjects taking part in study. * One product per reference and one per batch for the Spincontrol company’s sample collection. ‘The products were stored away from the light and at ambient temperature. 3.2.1. Product Application — Frequency ~ Methods For the treated group (group 2) ‘The products were applied daily, moming or evening. Application was undertaken by the subjects. The treatment consisted in a preliminary hair washing using the shampoo provided. A three- to-four minute penetration period was then heeded prior to rinsing. The conditioner was applied evenly over the entire scalp on wet hair following rinsing, being especially careful to apply the product right down to the hair root. The rinsing was undertaken at least five minutes after product application to guarantee its action. All of these recommendations were stipulated in the data sheet provided the subjects (See the protocol in annex) at the start of the study, as well as imparted orally during the first assessment on TO. For the control group (group 1) The subjects recruited for group 1 used their usual shampoo and at their usual intervals without, however, being allowed to switch brands/types for the entire duration of the study. They were not permitted to apply any hair care products. 3.2.2. Tolerance The incidents that occurred during the course of the study were listed by the study coordinator in the study binder. The nature, severity, date of appearance, duration, date of termination, assessment, and possible treatments undertaken were listed in detail in the observation notebook, along with the causes of the incidents observed. All serious undesirable effects were reported to the study monitor within 48 hours and confirmed in writing within three days 3.3. Choice of trial * This was an “open” study in which the investigator and the subjects were all aware of the nature of the products being tested. * This was a comparative study in which the results obtained by the treated group (group 2) were compared to the results obtained by the control group (group 1). * The subjects did not serve as their own control. SpincontroLB2C ECMN0-BC-MSOI-EC-RA{VO1) Products: Shampoo 304 170 Conditioner 509180, Confidential Document 3.4. Randomisation There was no randomisation carried out. The subjects selected were divided into group 1 (control) and group 2 (treated) in such a way so as to ensure that the two groups were homogeneous, both in terms of age of hair type (oily/dry).. 3.5. Assessment methods 3.5.1. Growth kinetics measurement The objective was to quantity the hair growth kinetics for both the treated and for the control ‘group respectively, and then to compare them, To do so, the technique consisted in measuring the length of a sample of 10 hairs after 28 days of treatment. During the initial period prior to treatment: a strand of hair, made up of about thirty hairs located on the top of the scalp, was selected and a length of this hair measuring two to three em was bleached starting at the root. As this bleaching operation did not penetrate the hair follicle, the hair was not physiologically disturbed and its capacity for growth was therefore unaffected. After applying the bleaching product for 20 minutes, it was then thoroughly rinsed. After 28 days of treatment: at least 10 hairs from this strand were pulled out for sampling purposes. The distance between the root and the limit of the bleached length was then measured on these 10 sample hairs. 3.5.2, Self-Evaluation Questionnaires A self evaluation was also undertaken by the group that had applied the treatment. In agreement with the sponsor, the questionnaire was organised in the following manner: Questionnaire composition: 1) Spontaneous responses: What did you think of the hair revitalising and growth accelerating treatment? Positive points / Negative points, 2) Cosmetic appreciation of the products and assessment of treatment efficacy: Possible responses to affirmations (questions from 1 to 10): © Entirely agree © Agree * Do not entirely agree © Donot agree at all Question 1: The shampoo’ texture is pleasant. Question 2: The conditioner’s texture is pleasant. Question 3: The scent of the products is pleasant. Question 4: My hair’s appearance has improved. Question 5: My hair is shinier. Question 6: My hair is healthier. Spincontrol-B2C EC-MX01-BC-MSO1-EC-RAVO1) Products: Shampoo 304 170 ~ Conditioner 509180 ‘Confidential Document Question 7: My hair quality has improved. Question 8: I noted that my hair grew faster. Question 9: I thought the treatment was effective, Question 10: Iam satisfied with the treatment. Question 11: The fundamental nature of my hair scalp has not changed (oily hair, appearance of dandruff, etc.). If “Do not entirely agree” or “Do not agree at all” explain why. I would be prepared to continue the treatment. (yes/no) L would be prepared to purchase these products. (yes/no) Global score attributed to the treatment (shampoo and conditioner) (n/10) ‘These documents were drawn up and processed using Scan’ Bac sofware (3SI company). The forms were read with the help of a Fujitsu M3096GX scanner and the same program. The data was then analysed and presented using Microsoft Excel. 3.6. Examination schedule The effects of the treatment were assessed over a 28-Jay period. The measurment procedures were as follows: On 70, the first day prior to product application: ‘Locating of the hair strand to be studied; © Bleaching a2 to 3 cm length of the hair strand, starting at the root. © Distribution of the products to the treatment group (group2) and usage recommendations On day T28: Rapid questioning about their tolerance to the products; Filling out of the self-evaluation questionnaire by the subjects (group 2); Locating of the bleached hair strand; Pulling out a minimum of 10 hairs; Measurement of the length of the samples; Termination of the study. Comment: The questionnaire was filled in by the subject prior to taking the hair samples so that the latter would not influence their judgement about the treatment. Measurement Dates: - T0 April 17 and 18, 2001 - day T28: May 15 and 16, 2001 Spincantral-RIC EC-MXOI-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 - Conditioner 509180, ‘Confidential Document 3.7. Presentation of results ‘Two type of presentation were made ~ global: corresponding to the average values for the entire test panel and expressed in the form of tables. - per subject: summary given a table of the all the values measured during the examinations. 3.7.1. Global results for the panel as a whole This presentation enables a rapid and overall visualisation of the evolution in the parameters under study. These global results are presented for the subjects as a whole on the final day of measuring at day 728. ‘The global results show the hair growth kinetics of the treated group and the control group as well as the differential between them. This differential is also expressed in terms of percentage in relation to the untreated control group (group 1). 3.7.2. Individual results For each subject, the overall gross length measurement, the average value of the 10 samples, and the dispersion (standard deviation) are presented. 3.7.3, Statistics Instrumental techniques The significance of the results was assessed using the Student’s t-test for non-paired groups (subject to application conditions being verified). The test was applied to the “gross” values of measured hair lengths. The acceptability threshold was set at 5 % Self-evaluation Frequency- charts were drawn up to present the results of the qualitative questions by taking a census of the number of volunteers and by tallying the frequency of the various possible responses (expressed as a percentage). The responses obtained for each question were then recorded in tabular form (individuals and frequencies). The statistical difference in the frequencies (%) was evaluated using a chi-square test. As for the responses that corresponded to agreement or disagreement, the 4 different responses were grouped into two categories as show below: AGREE ‘© Agree entirely © Agree DO NOT AGREE © Donot Agree entirely * Disagree ‘Spinconteol BC EC-MXO1-BC-MSOL-EC-RAV01) Products: Shampoo 304 170 ~ Conditioner 509180 Confidential Document 4, ETHICAL AND LEGAL CONSIDERATIONS 4.1, Study Personnel ‘The investigator guaranteed that all the individuals taking part in the trial had the required ‘qualifications and skills to adequately perform the diverse measurements. 4.2. Archiving of the data ‘Dual archiving was undertaken using two different media: paper documents and electronic data files. The paper files are archived in a locked cabinet, close to an extinguisher. The ‘electronic data-a stored on DAT cassettes and kept for a 10-years period. ‘The investigator retained a copy of the protocol signed by the study sponsor and by himself, as well as the original “observation records” (and all documents used to draw them up), the ‘participation consents, and documents of any sort related to the project for a 10-years period. ‘All documents are accessible for inspection by the study sponsor on his request. All elements are retained for a 10-years period as of the delivery date of the final report and they are available for inspection after reasonable notification by either a representative authorised by ‘the study sponsor or by study supervision authorities. The investigator will inform the study sponsor when the data is to destroyed following the 10-years period. 4.3. Insurance ‘The investigator and the study sponsor both took out an insurance policy covering their ci liability with regard to the subjects. “The study Sponsor took out an insurance policy covering potential liability resulting from the ‘est project with the AXA company, policy n° 132.131.25.04. The study Investigator took out an insurance policy covering his civil liability with the AXA. company, policy n° 79.191.004. 4.4, Declaration to the CNIL In accordance with the law covering “Information technology and freedom” dated January 6", 1978 the database needed to undertake all the studies carried out by Spincontrol had been declared to the CNIL. 4.5. Anonymity of the subjects The subjects were identified for the study sponsor by an alphanumeric code with five characters and by a number. A confidential computerised list, with the names and addresses of the volunteers, is kept at Spincontrol headquarters. Spincontrol-B2C EC-MX01-BC-MS01-EC-RA-(V01) Products: Shampoo 304 170 - Conditioner 509180, ‘Confidential Document 4.6. Consent to participate in the study ‘An information sheet was given to each subject providing full details about: = the study objectives, methods, and duration; = the expected benefits, constraints and potential risks of the test (particularly in case of study discontinuation); - the non-inclusion period, the amount of the compensation, the right of access to data files, and their subsequent destruction, 4.7. Confidentiality All information, data and results of the study are confidential. All persons having access to such data were informed that they are confidential. Medical information conceming the subjects obtained by the investigator during the recruitment and admission was handled confidentially in compliance with article 226-13 and the following of the Penal Code, as well as with the medical profession’s code of ethics (decree n° 95-1000, December, 1995). Identifiable information of a private nature was not imparted to the study sponsor. “The investigator and all persons conducting the testing are bound by professional secrecy concerning the nature of the products studied, the trials, the volunteers, and the final results” (excerpt from Article R 5120 of Decree n® 90-872 dated September 1990, under modified law n° 88-1138 dated December 20, 1988, regarding the protection of human biomedical research subjects: Huriet law). 48. Quality Assurance The study was subjected to quality assurance procedures in compliance with regulatory recommendations. The protocol and data were verified along with the specific procedures. The final report was reviewed to ensure that it accurately describes the methods and procedures, and that the results accurately reflected the raw data. Verifications of the data generated in this study were performed in accordance with “Procédure des Procédures” (procedure accomplishment) n° PRE-ASQ-1. ‘The final report was issued following a Quality Assurance evaluation of the completed draft report. This report includes all study details, along with to following additions: + The signature of the Investigator and the Study Director authenticating the report. + A statement certifying that the report has been subjected to a Quality Assurance Evaluation signed by the quality assurance manager. in EC-MX01-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 — Conditioner 509180. ‘Confidential Document 4.9. Annex documents not directly related to the study ‘The documents included in annex 5 correspond to an earlier study carried out by the BIODEV laboratory (F-87000 Limoges) which has not direct link to the Spincontrol company. The Spincontrol company leaves the entire responsibility for its contents to this study’s Investigator. 5. RESULTS 5.1. Compliance with the protocol The protocol was heeded as a whole. The subjects applied the product in a regular fashion. All the hair bleaching procedures carried out on TO and the hair samples obtained 28 days later took place under the conditions anticipated in the protocol and without any technical problems, Homogeneity of the groups Where the homogeneity of the two groups is concemed, their age was statistically identical both in the “treated” and the “control” group, with a respective average of 26.2 and 26.4 years of age. Representativeness in terms of either “oily” or “dry” hair was virtually equivalent in both groups (fig. 1). ‘Age - Reference group versus treated 12E-01 No Number of subjects with oily hail - treated 15 Number of subjects with dry hail - treated 14 Number of subjects with oily hail - Reference 15 Number of subjects with dry hail — Reference 7 Fiqure I: Homogencity ofthe “treated and the “control” groups with respect 10 the nature ofthe hair and average age ofthe subjects. Number of subjects At the conclusion of the study, the number of subjects in the “treated” and in the “control” group was, respectively, 29 and 32. In the “treated” group, the subject identified as SOUVA, ‘was excluded from the trial for non-compliance with the protocol because she became pregnant during the study. 5.2. Hair growth kinetics measurement results 5.2.1. Global results (annex 1) ‘The hair-growth length measurements were carried jut on samples having a minimum of 10 hairs for each subjects, as shown in figure 2. ‘Splncontrol-B2C EC-MX01-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 ~ Conditioner 509180 Confidential Document 5 See ; Hair growth in 28 days 10 i =a = Growth it SSS leaching at 20 Bleaching at TO 228 30 =————— Figure 2: Deseription ofthe length measurements carried out on the hair samples after 28 days of treatment (the ‘ordinate scale isin mn). These measurements made it possible to show that hair growth kinetics in the control group amounted to 14.7-41.6 mm. At the same time, the hair growth in the treated group appeared io be somewhat superior by 0.5 mm at it amounted to 15.2 +1.8 mm. The difference between the two groups is not statistically verified (p()>0.05). ‘The hair growth kinetics in the subgroups “dry hair treated” and “oily hair treated” compared to that of their equivalent in the control group does not show any statistically significant difference (p()>0.05). The subject MARC9 shows the greatest effect observed in the “treated” group, achieving a growth of 18.1 mm in 28 days of treatment. Compared to the average value obtained by the control group (14.7 mm), this subject presented a hair growth rate that is 23% higher. This maximum effect observed is only indicative and is not intended to be representative of the efficacy observed for the panel as a whole. 5.2.2. Interpreted results (Annex 2) Beyond the gross results obtained for the panel as a whole, and as is shown in figure 3, it appears that the growth kinetics are superior in the group of subjects who applied the treatment in relation to untreated group. ‘Spinconteol-B2C EC-MX01-BC-MSO1-EC-RA-(VO1) Products: Shampoo 304 170 — Conditioner 509180 ‘Confidential Document a es sus du Langusur de pousse ds chaveux Numi de st pours grup Figure 3:Comparaison of the hair growth kinetics of the subjects in the “treated” group and in the “control” group. ‘Sorted by ascending order of growth rate. This observation enables showing that 18 subjects in the “treated” g-oup, or 62.1 %, showed a hair growth rate (16.3 mm) superior by 7.1% following the 23 days compared to that observed on average in the “contro!” group subjects (14.7 mm). This difference appears to be statistically significant after 28 days of treatment (p(t)=0.0007; significant at 5%). 5.3. Self-evaluation results (Annex 3) The product evaluation questionnaire (shampoo and conditioner) submitted to the volunteers who had applied the product during the 28-days period shows a genuine appreciation for the products as much for their cosmetic characteristics as for their effectiveness. Cosmetic characteristics The responses concerning the cosmetic characteristics as a whole are in the majority and. significantly positive. The satisfaction felt by the subjects with regaré to the hedonistic factors. were broken down as follows: Yes Significant at 5%? The shampoo texture is pleasant: 69% Yes The conditioner texture is pleasant: 9% Yes The shampoo scent is pleasant: 2% Yes The conditioner scent is pleasant: 16% Yes Treatment efficacy The global efficacy of the treatment as a whole (shampoo + conditioner) was recognised by the majority of the subjects and in a significant fashion as shown below: Yes Significant at 5%? Hair appearance improved: 66% Yes Hair shinier: 2% Yes Hair healthi 83% Yes Spincontrol-B2C_ EC-MX01-BC-MS01-EC-RA-(V01) Products: Shampoo 304 170 - Conditioner 509180 ‘Confidential Document Hair quality improved: 66% Yes Hair grows faster: 76% Yes Hair growth acceleration effectiveness: 79% Yes Global satisfaction ‘The vast majority of the subjects who used the products are prepared to continue the treatment and purchase it. The average score attributed to the treatment is 7.5/10 Yes Significant at 5%? Will you continue the treatment? 93% Yes Will you purchase the treatment? 66% Yes Spontaneous comments (positive and negative points concerning the products) Globally and in a non-exhaustive way, the positive and negative points made by the subjects were: Positive Points ‘The conditioner’s pleasant scent (13%) The shampoo’s quality (7%) The treatment’ efficacy (6%) The hair’s improved appearance (19%) These spontaneous comments as a whole confirm the global appreciation of the treatment described in the questionnaire and presented above. At the same time, a few negative points were made spontaneously: Negative points The shampoo’s scent is not appreciated (5%) The shampoo is too liquid (5%) The conditioner makes the hair oily, it doesn’t untangle hair enough.... (13%) 5.4, Conclusion ‘The treatment, tested for a 28-day period by 29 subjects and compared to a control group of 32 subjects who did not apply the products, made it possible to show significantly accelerated hair growth kinetics of 7.1% for 62% of the subjects. The maximum effect observed on the group of treated subjects amounted to 18.1 mm in 28 days, equivalent to a growth rate 23% above the average value obtained by the control group (this is indicative information that is not representative of the efficacy observed on the panel as awhole). At the same time, 79% of the subjects questioned recognised that their had grown at an accelerated rate after 28 days of treatment (significant: p(t) <0.05), while 93% of them would be prepared to continue using it (significant: p(t)<0.05). Spincontrol-B2C EC-MX01-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 — Conditioner 509180 ‘Confidential Document ANNEX 1: GLOBAL RESULTS GROWTH KINETICS MEASUREMENTS Spincontro ECMXILECMSHLECRAVIY ‘Products: Shampoo 304170 Condor 519180 nfidential Document FC-MX01-BC-MSO1 Lah meneame cured ot othe ispaleny Spincontrol-B2C EC-MX01-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 - Conditioner $09180 Confidential Document EC-MX01-BC-MS01 Length measurements carried out the hair samples after 28 days of treatment Statistics [Ree yee ee er | I ii —— Reference group versus treated No Number of subjects with oily hail ~ treated 15 Number of subjects with dry hail ~ treated 14 Number of subjects with oily hail ~ Reference 15 Number of subjects with dry hall - Reference 7 Treated group versus reference group 5,75E-02 NO ily hair : Treated group versus Reference group _4.89E-01 NO Dry hair : Treated group versus Reference group _6,72E-02 NO Spincontrol BIC EC-MX(I-BC-MSOL-EC-RA-(VD1) Produets: Shampoo 304 170 ~ Conditioner 509180, ‘Confidential Document ANNEX 2: INTERPRETED RESULTS GROWTH KINETICS MEASUREMENTS Spincontrol-B2C EC-MX01-BC-MSOL-EC-RA-(V01) Products: Shampoo 304 170 —-Conditioner $09180 ‘Confidential Document EC-MX01-BC-MS01 SUJETS TRAITES PRESENTANT UNE CINETIQUE DE POUSSE DES CHEVEUX SUPERIEURE A LA VALEUR DE REFERENCE 166 159 158 157 139 142 Tas 149 BS 136 139 128 132 15s 157 123 29 Bs BH 165 14a 147 180 176 156 124 160 Hs 160 16s Mean (on) 12 147 29 “Number of tested subjects jamber of observed improvements rated tothe mean vakies observed on reference group (14.7; ed value) were of air growth in 28 days (18 subjects) ease in % of hair growth related to reference group (18 subjects) +f subjects presenting supenor bar growih compared tothe reference group atstcalsigaitcation~ Bilan test ~ Significant = Vest 9% Spincontrol-B2C EC-MXO1-BC-MSO1-EC-RAVO1) Products: Shampoo 304 170 - Conditioner 509180 Confidential Document ANNEX 3: RESULTS SELF —- EVALUATION Spincontral-B2C EC-MX01-BC-MSOI-EC-RA-(V01) Products: Shampoo 304 170 ~ Conditioner 509180 Confidential Document auewnzeg (enuapyuoy ‘0860s s2UOR BUS — OLY BOE 00% (10A)-V¥-93-10SIN-98-10XIN “9. ET a amps SA mero ore = z sams z scams sean, SA __coas SA awe AH A wos, SA aoa vie 6 Ta r mC 9 vr 7 ware or war Se 69 « 198 x 6 z yeu z 8 6 8 By « w Ca « e Ca % SN uN, % Suu % =, % E STUDY [bescRFrION OF THAT EVALUATION OF THE EFFICACY OF A HAIR GROWTH ACCELERATION TREATMENT BY: - HAIR GROWTH KINETICS MEASUREMENT - SELF-EVALUATION QUESTIONNAIRES © Number of subjects: Group I: 30 subjects who applied no hair treatment at all (Control group) Group 2: 30 subjects who applied the two products daily (Treated group) © Kinetics : TO-T28 jours Principal criteria for recruitment: Their average age and hair type (oily and dry) were equally represented within the 2 groups. Between 18 and 40 years of age. Measurement Dates: = TO: April 17 and 18, 2001 ~ day T28: May 15 and 16, 2001 PRODUCTS TRIAL MODALITIES: Shampoo Ref: 304 170 Conditioner Ref: 509 180 ‘© Application frequency : Daily © Choice of tial - “Open” ~ Comparative study : Treated group compared to reference group = The subjects did not serve as their own cortrol [Memionorocr 7 Tas days Bleaching oFhairs = ‘Uprooting of hairs . ‘Auto-evalustion questionnaire * The objective was to quantify the hair growth Kinetics for Bath the treated and for the control group respectively, and then to compare them, RESULTS AND CONCLUSION The treatment, tested for a 28-day period by 29 subjects and compared to a control group of 32 subjects who did not apply the products, made it possible to show significantly accelerated hair grawth kinetics of 117.1% for 62% of the subjects. ‘The maximum effect observed on the group of treated subjects amounted to 18.1 mm in 28 days, equivalent to a growth rate 123% above the average value obtained by the control group (this is indicative information that is not representative of the efficacy observed on the panel as a whole), At the same time, 79% of the subjects questioned recognized that their hair had grown at an accelerated rate after 28 days of treatment (significant: p(t)<0.05), while 93% of them would be prerared to continue using it (significant: p(t)<0.05) Spincontrol-B2C Products: Shampoo 304 170 ~ Conditioner 509180