Hair HealthNCT07880041
Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women
A study testing Nutraceutical supplements in people with Hair Health, run by LycoRed Ltd. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Health
- What is being tested?
- Nutraceutical supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant having signed an Informed Consent Form (ICF);
- Female participant aged 45 to 60 years, inclusive;
- Participant with skin type I to IV according to the Fitzpatrick scale;
- 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;
- Participant reporting self-perceived hair thinning or reduced hair density, with clinical confirmation by a qualified person*;
- Participant with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
Show all 13Show fewer
- Participant with previously colored hair, willing to maintain regular hair coloring practices consistently during the study period;
- Participant agreeing to have a shaved zone of 1.8 cm² on scalp area;
- 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;
- 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;
- Participant accepting not to bleach her hair or undergo a permanent waving throughout the study period;
- Participant willing and able to follow all the study procedures and restrictions and complete the whole study phase;
- Participant affiliated to a health social security system (according to French Law).
Who cannot join
- Male participant;
- Pregnant or breastfeeding participant;
- Participant with a BMI ≤ 17 or ≥ 32 kg/cm²;
- Participant who has undergone a hysterectomy and/or bilateral oophorectomy, or who presents with ovarian insufficiency;
- Participant presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
- Participant suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies);
Show all 15Show fewer
- 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);
- 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;
- 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;
- Participant with an history of sleeve or bypass;
- Participant with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
- 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;
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CPCAD - Centre de Recherche Clinique Appliquée à la Dermatologie
Nice
Anne-Claire Cathelineau, 04.92.03.62.40, anne-claire.cathelineau@qima.com
Mathilde AUBIN, 06.18.21.15.85, mathilde.aubin@qima.com
About this study
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.
- Conditions
- Hair Health
- Being tested
- Nutraceutical supplements, Placebo
- Keywords
- Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceutical supplementsDietary supplement
An oral capsule contains pytonutrients taken once a day with a meal
PlaceboDietary supplement
An oral capsule contains rice oil taken once a day with a meal
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical Supplement | Active comparator | LycoLush softgel Receives: Dietary Supplement: Nutraceutical supplements |
| Placebo | Placebo comparator | Placebo softgel Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baselibe to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magali Babled, Study director, CPCAD, Hôpital l'Archet 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880041
- Sponsor's protocol ID
- 2025-A01983-46
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women
- ClinicalTrials.gov ID
- NCT07880041
- Acronym / sponsor ID
- 2025-A01983-46
- Conditions
- Hair Health
- Keywords
- Nutritional Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical Supplement | Active comparator | Dietary Supplement: Nutraceutical supplementsLycoLush softgel |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo softgel |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participant having signed an Informed Consent Form (ICF);
- Female participant aged 45 to 60 years, inclusive;
- Participant with skin type I to IV according to the Fitzpatrick scale;
- 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;
- Participant reporting self-perceived hair thinning or reduced hair density, with clinical confirmation by a qualified person*;
Key exclusion criteria (15 listed)
- Male participant;
- Pregnant or breastfeeding participant;
- Participant with a BMI ≤ 17 or ≥ 32 kg/cm²;
- Participant who has undergone a hysterectomy and/or bilateral oophorectomy, or who presents with ovarian insufficiency;
- Participant presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutraceutical supplementsAn oral capsule contains pytonutrients taken once a day with a meal | Dietary supplement | Nutraceutical Supplement |
| PlaceboAn oral capsule contains rice oil taken once a day with a meal | Dietary supplement | Placebo |
Primary outcome
Efficacy of Nutraceutical Supplementation on Hair Growth After 6 Months
Time frame: 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.
1 secondary outcome
Efficacy of Nutraceutical Supplementation on Hair Density After 6 Months
Time frame: Baselibe to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hair Health
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Active, not recruiting
Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% Minoxidil
Scalp Health, Alopecia
Not yet recruiting
A Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults
Grey Hair, Hair Growth
Not yet recruiting
Colostrum and Gut Health
Gastrointestinal Health
Not yet recruiting
Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
Androgenic Alopecia, Healthy Adult Male
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magali Babled study director
CPCAD, Hôpital l'Archet 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraceutical supplements in people with Hair Health, run by LycoRed Ltd. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Claire Cathelineau (+33 (0)4.92.03.62.40, anne-claire.cathelineau@qima.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Nutraceutical Supplementation on Hair Growth After 6 Months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.