Clinical Studies Hairbell English Version

CONFIDENTIAL REPORTRéf : EC-MX01-BC-MS01

EVALUATION OF THE EFFICACY OF A HAIR GROWTH

ACCELERATION TREATMENT :

HAIR GROWTH KINETICS MEASUREMENT

SELF-EVALUATION QUESTIONNAIRES

REFERENCES OF THE TEST PRODUCTS :

Shampoo : 304 170

Accelerator Conditionner : 509 180

In vivo test on subjects

Study Sponsor: B2C

BP 61759061 ROUBAIX Cedex 01

SPINCONTROL Juillet 2001

Spincontrol-B2C EC- MX01-BC-MS01-EC-RA-(V01)Products: Shampoo 304 170 – Conditioner 509180 Confidential Document

238, rue Giraudeau37000 TOURS

CONTENTS

1. TRIAL CONDITIONS 2

1.1. Site of experimentation 21.2. Study Sponsor 21.3. Study Monitor 21.4. Investigator 21.5. Scientific Manager & Study Director 21.6. Technician 21.7. Quality Assurance Manager 2

2. STUDY SUMMARY 3

2.1. Objectives 32.2. Study Population 32.3. Trial period, kinetics, and schedule 32.4. Study Design 3

3. METHODOLOGY 4

3.1. Subject Selection 43.1.1. The inclusion, exclusion and restrictions criteria defined in the protocol are listed below 43.1.2. Non-inclusion criteria 53.1.3. Proscriptions and restrictions 5

3.2. Product Presentation 53.2.1. Product Application – Frequency – Methods 63.2.2. Tolerance 6

3.3. Choice of trial 63.4. Randomisation 73.5. Assessment methods 7

3.5.1. Growth kinetics measurement 73.5.2. Self-evaluation Questionnaires 7

3.6. Examination schedule 83.7. Presentation of results 9

3.7.1 Global results for the panel as a whole 93.7.2 Individual results 93.7.3 Statistics 9

4. ETHICAL AND LEGAL CONSIDERATIONS 10

4.1. Study Personnel 104.2. Archiving of the data 104.3. Insurance 104.4. Declaration to the CNIL 104.5. Anonymity of the subjects 104.6. Consent to participate in the study 114.7. Confidentiality 114.8. Quality of Assurance 114.9. Annex documents not directly related to the study 12

5. RESULTS 12

5.1. Compliance with the protocol 125.2. Hair growth kinetics measurement results 12

5.2.1. Global results (Annex 1) 125.2.2. Interpreted results (Annex 2) 13

5.3. Self-evaluation results (Annex 3) 145.4. Conclusion 15


ANNEX 1: GLOBAL RESULTS – GROWTH KINETICS MEASUREMENTSANNEX 2: INTERPRETED RESULTS – GROWTH KINETICS MEASUREMENTSANNEX 3: RESULTS – SELF-EVALUATIONANNEX 4: COPY OF THE PROTOCOLE (French Version)ANNEX 5 : CERTIFICATIONS AND ATTESTATIONS


1. TRIAL CONDITIONS

1.1. Site of Experimentation

SPINCONTROL238 rue Gireaudau – F-37000 TOURS – FRANCETel: +33 (0)2 47 37 62 79Fax: +33 (0)2 47 37 58 28e-mail: [email protected]

1.2. Study Sponsor

B2CBP 617F-59061 ROUBAIX Cedex 01 – FRANCE

1.3. Study Monitor

S.CATRYSSEB2CBP 617F-59061 ROUBAIX Cedex 01 – FRANCETel: +33 (0)3 20 26 27 28Fax: +33 (0)3 20 26 27 48

1.4. Investigator

P.BEAU, Ph.DManagerSPINCONTROL

1.5. Scientific Manager & Study Director

J.C.PITTET, Ph.DSPINCONTROLTel: +33 (0)2 47 37 12 86e-mail: [email protected]

1.6. Technician

S.JACOBSPINCONTROL

1.7. Quality Assurance Manager

C.PERRIERSPINCONTROLTel: +33 (0)2 47 37 09 49


mailto:[email protected]

mailto:[email protected]

2. STUDY SUMMARY

2.1. 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 170Conditioner 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:T0 T28 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, i.e. the effects of the treatment observed on Group2

(treated) were compared to the natural variations observed on Control Group 1.- The subjects did not serve as their own control reference.


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 (T28 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.e., 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;


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-inclusion 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 l209-5);

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 l209-6).

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.


Shampoo Ref.: 304 170Conditioner 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, morning 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 T0.

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.

Spincontrol-B2C EC-MX01-BC-MS01-EC-RA-(V01)

EC- MX01-BC-MS01-EC-RA-(V01)Products: Shampoo 304 170 – Conditioner 509180 Confidential Document

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 cm 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 Do not agree at all




Question 1: The shampoo’s 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.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: I am 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)I 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-day period. The measurment procedures were as follows:

On T0, the first day prior to product application:

Locating of the hair strand to be studied; Bleaching a 2 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







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 T28.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-evaluationFrequency- 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




Do not Agree entirely Disagree




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 civil liability with regard to the subjects.

The study Sponsor took out an insurance policy covering potential liability resulting from the test 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 th, 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.




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 concerning 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).

4.8. 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.




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 T0 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 groupsWhere the homogeneity of the two groups is concerned, 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).

Bilateral t test SignificantHomogeneity of the panel at T0 P(t) difference 5% ?Age - Reference group versus treated 8.92E-01 No

Nombre de sujets Number of subjects with oily hail – treated 15Number of subjects with dry hail – treated 14Number of subjects with oily hail – Reference 15Number of subjects with dry hail – Reference 17

Figure 1: Homogeneity of the “treated” and the “control” groups with respect tothe nature of the hair and average age of the subjects.

Number of subjectsAt 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 iut on samples having a minimum of 10 hairs for each subjects, as shown in figure 2.




Figure 2: Description of the length measurements carried out on the hair samples after 28 days of treatment (theordinate scale is in mm).

These measurements made it possible to show that hair growth kinetics in the control group amounted to 14.7 ±1.6 mm.At the same time, the hair growth in the treated group appeared to 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(t)>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(t)>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.




Hair growth in 28 days

Bleaching at T0

Growth limits at 28 days

10

11

12

13

14

15

16

17

18

19

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31

TRAITES

NON TRAITES

Numéro de sujet pour les groupes "Traité" et "Référence"

Long

ueur

de

pous

se d

es c

heve

ux e

n m

m

Comparaisons des cinétiques de pousse de cheveux des sujets du groupe "Traité" et "Référence"

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” group, or 62.1 %, showed a hair growth rate (16.3 mm) superior by 7.1% following the 28 days compared to that observed on average in the “control” 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 regard to the hedonistic factors were broken down as follows:

Yes Significant at 5%?The shampoo texture is pleasant: 69% YesThe conditioner texture is pleasant: 69% YesThe shampoo scent is pleasant: 72% YesThe conditioner scent is pleasant: 76% 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% YesHair shinier: 62% YesHair healthier: 83% Yes

Hair quality improved: 66% YesHair grows faster: 76% YesHair 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% YesWill 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’s 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 a whole).

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).




ANNEX 1:GLOBAL RESULTS

GROWTH KINETICS MEASUREMENTS







EC-MX01-BC-MS01Length measurements carried out the hair samples after 28 days of treatment

Statistics

Bilateral t test SignificantHomogeneity of the panel at T0 P(t) difference 5% ?Age – Reference group versus treated 8.92E-01 No

Nombre de sujets Number of subjects with oily hail – treated 15Number of subjects with dry hail – treated 14Number of subjects with oily hail – Reference 15Number of subjects with dry hail – Reference 17

Bilateral t test SignificantEfficacy of the treatment P(t) difference 5% ?Treated group versus reference group 5.75E-02 NOOily hair : Treated group versus Reference group 4.89E-01 NODry hair : Treated group versus Reference group 6.72E-02 NO




ANNEX 2:INTERPRETED RESULTS

GROWTH KINETICS MEASUREMENTS




EC-MX01-BC-MS01SUJETS TRAITES PRESENTANT UNE CINETIQUE

DE POUSSE DES CHEVEUX SUPERIEURE A LA VALEUR DE REFERENCE

29 =Number of treated subjects 18 =Number of observed improvements related to the mean values observed on reference group (>14.7 ; red value) 16.3 =Average of hair growth in 28 days (18 subjects) 7.1% =In crease in % of hair growth related to reference group (18 subjects)62.1% =% of subjects presenting a superior hair growth compared to the reference group0.0007 =Statistical signification – Bilateral t test – Significant = Yes at 5%




ANNEX 3:RESULTS

SELF – EVALUATION




Self-evaluation resultsEC-MX01-BC-MS01


STUDY : EC-MX01-BC-MS01

DESCRIPTION OF TRIAL :

EVALUATION OF THE EFFICACY OF A HAIR GROWTH ACCELERATION TREATMENT BY:

- HAIR GROWTH KINETICS MEASUREMENT- SELF-EVALUATION QUESTIONNAIRES

Number of subjects : 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)

Kinetics : T0 – 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: - T0: April 17 and 18, 2001

- day T28: May 15 and 16, 2001PRODUCTS – TRIAL MODALITIES :

Shampoo Ref.: 304 170Conditioner Ref.: 509 180

Application frequency : Daily Choice of trial : - “Open”

- Comparative study : Treated group compared to reference group- The subjects did not serve as their own control

METHODOLOGY :

T0 T28 days

Bleaching of hairs ■Uprooting of hairs ■Auto-evaluation questionnaire ■

The objective was to quantify the hair growth kinetics for both 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 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 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 prepared to continue using it (significant: p(t)<0.05).

Spincontrol-B2C

EC- MX01-BC-MS01-EC-RA-(V01)Products: Shampoo 304 170 – Conditioner 509180


Clinical Studies Hairbell English Version

Documents

selfevaluation results

results selfevaluation

study summary

global results annex

study population

study design

study personnel

interpreted results