The aim of this test was to determine the efficacy of an anti-gray hair treatment: Ref. Anti-Gray Lotion batch E0112009
This evaluation was done by: Colorimetric analysis of hair images. Self-evaluation questionnaire
The evaluation was carried out for a total period of 28 days of application.
2.2. Population
The study was conducted on 20 healthy adults. Equal numbers of men and women were recruited. The subjects were required to strictly comply with the inclusion/exclusion criteria defined in section 4.1.1
For inclusion, the subjects had to have light to dark brown hair with about 50 to 80% gray hair, evenly distributed if possible. 2.3. Timetable and determinations
The study was conducted from January to February 2002.
Timetable: T0 T7 days T14 days T28 days
January 24 2002 January 31 2002 February 07 2002 February 21 2002 - Photogr aphic acquisition of hair - Telepho ne interviews on product acceptance - Photogra phic acquisition of hair - Self- evaluation - Photogra phic acquisition of hair - Self- evaluation questionnaires questionnaires
Comments: - Carrying out the T28 days time point depended on the results obtained at T14 days. - A telephone survey was conducted 7 days after the first application of the product to verify color changes to the hair and subject satisfaction.
2.4. Choice of the study
- Open. - Non-comparative study. - Subjects were their own controls in relation to T0, i.e prior to treatment.
3. LEGAL ASPECTS
3.1. Qualification of personnel
The Investigator certifies that the Study Coordinator and all persons participating in this study were qualified for the skills required for its realization.
3.2. Data storage
The Investigator stored the data on two supports, i.e. paper and computer. Paper storage is in a special cabinet, locked and in proximity to a fire extinguisher. Computer storage is on DAT tape stored for 10 years. The Investigator will keep a copy of the protocol signed by the sponsor and himself, the case report forms and all documents used to fill them out, study participation consent forms, original documents of all types and all documents concerning the project for 10 years after the final report is remitted. All these documents will remain available for inspection within a reasonable time period for an authorized representative of the sponsor or by legal authorities. The investigator will inform the sponsor when data destruction is planned after 10 years
3.3. Protocol amendment
The Sponsor is informed that any modification he introduces leading to a protocol amendment will generate additional costs.
3.4. Insurance
The Sponsor covered this study with an insurance policy taken out with:
AXA No. 132.131.25.04
The Investigator took out a liability policy with:
AXA No. 79.191.004.
The investigator and the sponsor took out separate liability insurance policies to protect the subjects. Extract of modified law No. 88-1138 dated December 20, 1988, concerning the protection of persons engaged in biomedical research (article L 209-7): "For biomedical research without direct individual benefit, the Sponsor assumes even in the absence of fault indemnity for the harmful effects of research on the person who is engaged and that of his beneficiaries, without invoking a third party or the dropout of the person who initially consented to participate in the research".
3.5. Declaration to the CNIL (National Data Protection Commission)
In application of the "Data and Personal Freedom" law dated January 6, 1978, the database required for carrying out all SPINCONTROL studies has been declared to the National Commission on Data and Personal Freedom.
3.6. Subject anonymity
The subjects were identified for the sponsor by a 5-character alphanumeric code and by a number.
3.7. Consent for participation in the study
A form was remitted to each subject in order to define: - the aim of the study, its methodology and duration, - any expected cosmetic benefits, restrictions related to the study and predictable risks, including interruption of the study before its termination, - the non-inclusion period, the amount of indemnity if applicable, the possibility for the subject to verify the accuracy of the information in their file and its subsequent destruction This information enabled the subject to sign a form for free, informed and express consent with full knowledge.
3.8. Confidentiality
All information, data and results of the study are confidential. All persons having access to this information, data and results have been informed that they are confidential. All information on the health status of subjects and the results of clinical examinations conducted before the study for their recruitment, selection and admission are subjected to the rules of medical secrecy compliant with article 226-13 and the following of the Penal Code and the Medical Ethics Code (decree No. 95-1000 of December 6, 1995): in no case can they be communicated to the Sponsor with their identity.
"Investigators and all persons cooperating in trials are bound by professional confidentiality especially concerning the nature of the products studied, trials, persons included and the results obtained" (extract of article R 5120 of application decree No. 90-872 dated September 27, 1990 of modified law No. 88-1138 dated December 20, 1988, concerning the protection of persons engaged in biomedical research: "Huriet" law).
3.9. Quality Assurance
The entire study brief (protocol, results, report and all associated documents) has been controlled by Quality Assurance in compliance with regulatory stipulations and existing procedures. The procedures for the complete audit of this study are described in the "Procedure for Procedures" No. PRE-ASQ-1. The investigator is ready to receive and cooperate with any audit designated by the sponsor to verify that the study was conducted in compliance with the protocol and existing procedures.
3.10. Regulations
This study without direct therapeutic finality for the subject was conducted in compliance with the most recent recommendations of the World Health Association (1964 Helsinki Declaration amended at Somerset West, Republic of South Africa, 1996). This study was not within the scope of French law No. 88-1138 dated December 20, 1988 modified by laws No. 90-86 dated January 23, 1990 and No. 94-630 of July 25, 1994, as indicated in the "Guide to legislative and regulatory texts" (BOMS (Health Ministry Official Bulletin) No. 91/13 bis) concerning the protection of persons engaged in biomedical research. Thus, no information was communicated to the national file of persons engaged in biomedical research without direct individual benefit and the opinion of the Institutional Review Board (Ethics Committee) was not sought, but the spirit of decree no. 90-872 dated September 27, 1990 on the application of this law was heeded.
3.11. Practical considerations
Prior agreement between the Investigator and the Sponsor of the present study will be required for any publication, regardless of which party so desires it.
4. METHODOLOGY
4.1. Subject selection
The SPINCONTROL panel was composed of subjects having previously responded to a computerized questionnaire concerning their medical history, allergies, health and cosmetic care practices, and including various administrative information. A licensed esthetician was responsible for questionnaires.
The procedure for recruitment, selection, and admission of willing subjects, after free, informed and express consent for study participation, was prepared to guarantee clear and precise information, enabling them to determine the aim and consequences of their consent. In particular, this procedure included: - A preliminary interview where they were informed of the objective of the study protocol, indemnity procedures where applicable, and the expected cosmetic benefits, study-related limitations and predictable risks. - Reading an information sheet covering the essential parts of the study and the signature of a free, informed and express consent form by the subject: this enables the subjects to decide upon their inclusion based on the conditions proposed. - This consent enabled subjects to be covered by the liability insurance taken out by the sponsor and investigator once the subject was definitively admitted to the study by the coordinator.
Subjects recruited were selected under the responsibility of the investigator and study coordinator on the basis of the inclusion/non-inclusion criteria and proscriptions/restrictions defined in the protocol (copy in appendix).
There were 20 subjects selected for this study. In order to compensate for possible withdrawals of one or several subjects, two additional subjects were recruited. The results are presented for all subjects present at the last examination time in the study (T28 days).
4.1.1. Review of principal inclusion criteria
Concerning the study: Male or female subjects; Caucasian; 30 to 80 years of age (no limit); Having dark hair (light to dark brown, black); With gray hair evenly distributed over the entire scalp with at least about 50% gray hair; Not having applied hair coloring for at least 8 months; Accepting to wash their hair the day before measurements with the shampoo provided; Having healthy skin (absence of psoriasis, eczema, erythema, edema, scars, wounds, lesions), on the scalp in particular; Not pregnant nor breast feeding for at least 3 months; Not under a hormone treatment for a pathology, e.g. a thyroid problem.
Not presenting skin hypersensitivity to cosmetic products, to hair colorants in particular; Not having atopic skin; Pledging not to undergo UV exposure in an institute throughout the study; Pledging not to tint or bleach the hair throughout the study; Pledging not to have a haircut throughout the study.
4.1.2. Review of principal proscriptions and restrictions
No other cosmetic product for coloring, bleaching or treating hair was to be applied throughout the study. No shampoo other than that furnished 48 hours before the examination days. In no case were the subjects to have a haircut throughout the study.
4.1.3. Acceptance of the use of images (Appendix 2) Each subject was asked to sign an agreement for the commercial use of the photos taken and for his/her possible participation for testimonial on a television show.
4.2. Description of the product
The product to test was provided by the sponsor. The product was packaged in a 200 ml bottle with pump dispenser. The sponsor was responsible for the manufacture, packaging, identification, determination of purity, composition, safety and other characteristics of the product tested. The sponsor agreed to provide an attestation of absence of toxicity of the product tested.
Ref.: ANTI-GRAY LOTION batch E0112009
The sponsor has provided to the coordinator with complementary quantities of products required for the study.
The sponsor provided for the study: The number of products necessary for the subjects participating in the study. A sufficient quantity of products for the additional subjects in the study. One product per reference and per batch for the Spincontrol sample collection.
4.2.1. Application of products, frequency, procedures
The product had to be applied 2 to 3 times a week, i.e. every 3 days on average. Application was by carried out by the subjects. The procedure involved first washing the hair with the shampoo provided, drying, and then application of the product to all the hair. After application, gentle friction distributed the product uniformly, although avoiding direct contact with the scalp.
4.3. Choice of the study
This was an "open" study, i.e. both the investigator and the subjects knew what product was being applied. The study was non-comparative The subjects were their own controls in comparison to the time before treatment, T0.
4.4. Evaluation techniques
4.4.1. Measurement of hair color
The aim of the study was to quantify the change in hair color in a region previously defined and identical at all examination times for the same subject.
The technique involved acquiring a photographic profile of the entire head of hair in standard "daylight" illumination conditions. After this, a 40 x 50 mm region of interest, i.e. about 20 cm, was defined on the image. Image analysis of this acquisition involved extracting the images mean of gray levels as well as the proportion of white pixels after thresholding (S=120 on a gray scale from 0 to 255). This proportion is directly related to the "number of white hairs in the region examined. A comparison of this proportion at the different time points was used to determine darkening of the hair and the disappearance of gray hair resulting from the treatment.
T0 T14 days T28 days
Fig 1: Position of the region for measuring the gray scale and the number of pixels higher than the threshold (S=120).
4.4.2. Self-evaluation questionnaire
A self-evaluation was conducted both at T14 days and T28 days on the items defined in the protocol. These questionnaires were prepared and processed using ScanBac software (3SI). They were read with a Fujitsu M3096GX scanner and the same software. The data were then analyzed and presented using Excel (Microsoft).
4.5. Examination schedule
The effect of the treatment was determined after 14 and 28 days. A telephone survey was conducted on day 7 to determine recoloration progress and subject satisfaction.
Dates: T0: January 24, 2002 T7 days: January 31, 2002 T14 days: February 07, 2002 T28 days: February 21, 2002
4.6. Presentation of the results
Two types of presentation were adopted: - overall: corresponding to the mean values of the entire panel and expressed in tables and graphs.
- per subject: tabular summary of all values acquired during the examinations.
4.6.1. Overall results with the entire panel
This presentation provides a rapid and overall view of changes in the parameters studied. These overall results are presented for all the subjects present at the last measurement (T28 days).
4.6.2. Individual results
All raw measurements of the mean gray level and of the number pixels above and below the threshold are presented for each subject.
4.6.3. Statistics
I nstrumental techniques
The significance of the results was determined using Student's t test for paired data (provided product conditions of application are verified). The test was applied to raw data and to the changes of parameters over time.
The acceptance threshold was set at 5%.
Self-evaluation
The frequency tables expressing all the qualitative variables will be established by tallying the total test population and calculating the frequency of their various possible responses (given in percentages). For each question, the results are presented as tables (population and frequencies). The statistical difference of frequencies (%) was determined with a chi-square () test. For questions involving agreement or disagreement, 1 type of distribution is presented:
"Agree" distribution - the 4 responses were clustered in two non-symmetrical classes
Agree entirely AGREE Agree Do not agree entirely
Disagree DISAGREE
The latter presentation expresses all the "agrees," regardless of the degree of acceptance.