Effectiveness and Safety of Cellbooster Hair in Healthy Subjects

Inclusion Criteria:

1. Healthy subject.
2. Sex: male and female.
3. Phototype I to IV.
4. Age: from 18 years old.
5. Subject with low to moderate capillary density: - Male with hair loss grade II to IV on Hamilton scale modified by Norwood - Female with hair loss grade I to II on Ludwig scale
6. Proportion of hair in telogen phase ≥ 20% for the men and ≥ 15% for the women.
7. Subject with a total hair density ≥ 150 hair/cm² on test area.
8. Agreeing to have one shaved zone of 1.5cm X 1.2cm on the scalp (vertex area) during the study for hair assessments.
9. With dark brown or black hair at the root.
10. With hair length > 3 cm on vertex, and agreeing to keep this defined minimum length during the whole study duration.
11. Subject requiring an aesthetic treatment for reduced hair quality and hair density.
12. Subject willing to abstain from other scalp and hair aesthetic procedure through the entire study duration.
13. Subject agreeing to keep the same hair cut during all the study.
14. Subject having given their free, express, and informed consent.
15. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
16. Subject registered to a social security scheme.
17. Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.
18. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion Criteria:

In terms of population

1. Pregnant or nursing woman or planning a pregnancy during the study.

2. Studied zone with white or blond hair (coloured white hair also excluded to avoid affecting the PTG count).

3. With hair coloured, bleached at the root or permed.

4. Subject wearing a wig.

5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

6. Subject in a social or sanitary establishment.

7. Subject participating in another research on human beings or being in an exclusion period for a previous study.

8. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.

   In terms of associated pathology

9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety at the investigator appreciation.

10. Subject having history of severe allergy or anaphylactic shock.

11. Subject having history of allergy or hypersensitivity to one of the components of the tested device and or to any excipient of Xylocaine®

12. Subject having history of hypersensitivity to the antiseptic solution.

13. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.

14. Dermatological scalp disorders (ex: psoriasis, scalp dermatitis including seborrheic dermatitis, eczema, pre-cancerous or cancerous lesions, alopecia areata, fungal or bacterial infection, ringworm, lice or flea infestation) or poor hygiene.

15. Suffering from alopecia of special origins: chemotherapy induced (intoxication, drugs), or result from a chronic disease (genetic, endocrinological (excluding androgenetic alopecia)), immunological deficiencies…), result from injury or skin damage, alopecia of infectious origin (mycosis,…), scarring alopecia, psychological disorders (trichotillomania, trichokryptomania).

16. Subject with any form of bleeding disorders.

17. Subject with varices on the area (scalp).

18. Subject with inflammation or infection on the scalp.

19. Subject predisposed to keloids or hypertrophic scarring or having healing disorders.