ClinicalTrials.gg
RecruitingNCT07880041Updated Oct 19, 2026

Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women

An interventional study of Nutraceutical supplements and Placebo in Hair Health, sponsored by LycoRed Ltd.. Recruiting at 1 site in France. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by LycoRed Ltd. · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).
  • Started Jun 2026; still recruiting 5 months later.
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

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.

02

Conditions studied

  • Hair Health

Keywords

  • Nutritional Supplement
03

In context

Lead sponsor

LycoRed Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Nutraceutical Supplement

    LycoLush softgel

    Dietary Supplement: Nutraceutical supplements

  • Placebo comparator
    Placebo

    Placebo softgel

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementNutraceutical supplements

    An oral capsule contains pytonutrients taken once a day with a meal

  • Dietary supplementPlacebo

    An oral capsule contains rice oil taken once a day with a meal

06

What researchers measure

Primary outcomes

  1. Efficacy of Nutraceutical Supplementation on Hair Growth After 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.

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Efficacy of Nutraceutical Supplementation on Hair Density After 6 Months

    Change from baseline in the following parameters from the PTG analysis after 6 months of treatment in hair density

    Time frame: Baselibe to 6 months

07

Study locations

1 of 1 sites recruiting
  • CPCAD - Centre de Recherche Clinique Appliquée à la Dermatologie
    Nice, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 19, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07880041
Lead sponsor
LycoRed Ltd.
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Jun 1, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Anne-Claire Cathelineau
Contact
anne-claire.cathelineau@qima.com
+33 (0)4.92.03.62.40
Mathilde Aubin
Contact
mathilde.aubin@qima.com
+33 (0)6.18.21.15.85
Magali Babled
study director · CPCAD, Hôpital l'Archet 2

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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