Recruiting
Not applicable
Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women
Condition(s) studied
Hair Health
Investigational drug(s) / intervention(s)
Nutraceutical supplementsPlacebo
Nutraceutical supplements: An oral capsule contains pytonutrients taken once a day with a meal
Placebo: An oral capsule contains rice oil taken once a day with a meal
Study summary
This is a randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of an orally administered gel formulation in up to 60 participants who meet the predefined inclusion and exclusion criteria. Participants will receive either the investigational nutraceutical supplement or a matching placebo daily for 6 months. The primary objective is to quantitatively evaluate the effect of the nutraceutical supplement, compared with placebo, on hair growth in premenopausal and menopausal women using the phototrichogram method.
Eligibility
Inclusion Criteria:
1. Participant having signed an Informed Consent Form (ICF);
2. Female participant aged 45 to 60 years, inclusive;
3. Participant with skin type I to IV according to the Fitzpatrick scale;
4. Participant experiencing irregular menstrual cycles and vasomotor symptoms (e.g., hot flashes) for more than 6 months, without having experienced complete amenorrhea for 12 consecutive months OR Participant with a spontaneous amenorrhea lasting 12 months or more, not attributable to any pathological or hormonal cause;
5. Participant reporting self-perceived hair thinning or reduced hair density, with clinical confirmation by a qualified person\*;
6. Participant with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
7. Participant with previously colored hair, willing to maintain regular hair coloring practices consistently during the study period;
8. Participant agreeing to have a shaved zone of 1.8 cm² on scalp area;
9. Participant accepting not to use any product for scalp care other than non-treating shampoo. Hair gel, spray and styling product are authorized except on days of visit to center;
10. Participant accepting not to take any treatment (oral or topical route) that could interfere with hair growth, diameter or hair fall throughout the study period;
11. Participant accepting not to bleach her hair or undergo a permanent waving throughout the study period;
12. Participant willing and able to follow all the study procedures and restrictions and complete the whole study phase;
13. Participant affiliated to a health social security system (according to French Law).
Exclusion Criteria:
1. Male participant;
2. Pregnant or breastfeeding participant;
3. Participant with a BMI ≤ 17 or ≥ 32 kg/cm²;
4. Participant who has undergone a hysterectomy and/or bilateral oophorectomy, or who presents with ovarian insufficiency;
5. Participant presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
6. Participant suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies);
7. Participant having any other concomitant dermatological affection of the scalp (psoriasis, seborrheic dermatitis, eczema, scarring alopecia or autoimmune hair loss, severe androgenetic alopecia, recent acute telogen effluvium);
8. Participant suffering from a recurrent, acute, non-stabilized or evolving disease judged by the investigator able to interfere with the study needs and hair growth;
9. Participant with an history of eating disorder (e.g. anorexia, food allergy) or gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
10. Participant with an history of sleeve or bypass;
11. Participant with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
12. Participant having had surgical intervention for capillary correction (e.g., hair transplant) or intending to have recourse to this surgery during the entire study period;
13. Participant that has applied or taken prior to the start of the study (screening) the following treatments and/or procedures:
Participant taking any other medical treatment (topic or per os) likely to interfere on hair growth or hair loss within 6 months prior to the screening visit; 15. Participant following a long period (\>30 days) treatment of anti-inflammatory within 4 months prior to the start of the study (screening visit); 16. Participant taking topic cosmetic treatment or per os nutraceutical supplement likely to interfere on hair growth or hair loss during the last 3 months prior to the screening visit; 17. Participant having a topical or oral route treatment of the scalp (anti-seborrheic, anti-dandruff, daily friction) within 2 weeks prior to the screening visit; 18. Participant who has been exposed within one month prior to the screening visit in an intense or excessive manner to sun (natural or artificial) or during the study; 19. Participant having a wig or hair extension; 20. Protected participant as defined in the Articles of the French Public Health Code. Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care, or person admitted to a health or social institution for purposes other than the research.
Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent; 21. Participant unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function; 22. Participant currently participating in another clinical study or being in an exclusion period of another clinical study; 23. Subject having received 6000 euros indemnities for participation in clinical trials/investigations in the 12 previous months, including participation in the present study (according to French Law).
Primary outcome measure(s)
- Efficacy of Nutraceutical Supplementation on Hair Growth After 6 Months — Baseline to 6 months
The primary endpoint is the change from baseline in the density of anagen-phase hair per cm² (DA) after 6 months of use.
Trial sites (1)
| Facility | City | Region | Status |
| CPCAD - Centre de Recherche Clinique Appliquée à la Dermatologie |
Nice |
France |
Recruiting |