Nutraceutical supplement for hair growth in midlife women
Official title: Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women
Run by LycoRed Ltd. · NCT07880041 · Data updated 2026-11-12
A 6-month, randomized, placebo-controlled test to see if a nutraceutical gel helps hair growth in premenopausal and menopausal women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 60 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | LycoRed Ltd. Industry-sponsored |
| Locations | 1 site (Nice) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07880041 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 45–60 with irregular menstrual cycles or amenorrhea for non-pathologic reasons, self-reported hair thinning, and the ability to comply with study procedures.
✕Probably not a fit
Women outside the age range, without hair thinning, or unable to meet the scalp preparation requirements may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled study enrolling up to 60 women aged 45–60 with irregular cycles and vasomotor symptoms. Participants will receive either the investigational nutraceutical gel or a matching placebo daily for 6 months. Hair growth will be measured quantitatively using the phototrichogram method to compare changes between groups. The study also monitors safety and tolerability of the gel formulation. Eligible participants must meet specific inclusion criteria related to hair concerns, scalp condition, and hair length, with a shaved scalp area for standardized assessment.
Why it matters
Potential benefit: If successful, participants may experience improved hair growth and hair quality from the nutraceutical supplement.
How similar studies have gone: Previous studies of similar nutraceutical approaches have shown variable results; this study adds randomized controlled data for hair outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
CPCAD - Centre de Recherche Clinique Appliquée à la Dermatologie
Nice, France Recruiting
Study contacts
- Study coordinator: Anne-Claire Cathelineau
- Email: anne-claire.cathelineau@qima.com
- Phone: +33 (0)4.92.03.62.40
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.