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Hair LossNCT07556016

Evaluation of the Performance of a Nutricosmetic on Hair & Scalp in Women and Men After 3 and 6 Months

A study testing Active nutricosmetic in people with Hair Loss, run by L'Oreal at 4 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In order to validate the product performance, L'Oréal R\&I decided to conduct a new clinical study. The final product is intended to be performant in men and women. Therefore, L'Oréal R\&I wanted to conduct the clinical study on both these populations and compare the efficacy of the product to a placebo. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hair Loss
What is being tested?
Active nutricosmetic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
239 participants
Where
4 sitesFrance
Study dates
4 Nov 2025to 31 Jul 2026
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy subject and good general health
  • Man and woman
  • Between 18 and 65 years
  • Phototype II to IV (Fitzpatrick Classification scale)
  • BMI between 18.5 and 29.9
  • With dark brown or black hair at the root
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  • Subject agreeing to take the given Nutricosmetic: 2 capsules per day during 6 months and not introduce new nutritional supplement during the study.
  • Subject agreeing to not change sport activities (type and frequency of activities) throughout the entire course of the study
  • Subject agreeing to a stable diet with no change of dietary habits, e.g. no start a fasting cure throughout the entire course of the study
  • Subject agreeing to keep the same hair dyeing and frequency (if dyeing) during the whole study and at least from the previous month of starting.
  • Subject agreeing to keep the same shampoo frequency during all the whole study.
  • Subject with a stade IIIv or IV on the Hamilton scale amended by Norwood for men and with a grade I on the Ludwig scale for women.
  • Proportion of hair in telogen phase ≥ 20% for the men and ≥ 15% for the women.
  • Subject with a total hair density ≥ 150 hair/cm² on test area.
  • Subject agreeing to have one shaved zone of 1.2 x 1.5cm on the vertex area at each visit and during the whole study.
  • Subject accepting to have hair lock of about 135 hairs cut on D0 and M6
  • Subject with a minimum hair length of 6 cm on the vertex and accepting to keep this minimum length during the study.
  • Having given freely and expressly his/her informed consent.
  • Psychologically able to understand the study related information and to give a written informed consent.
  • Affiliated to a health social security system.
  • Female of childbearing potential must use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.
  • Subject agreeing to no increase his/her cigarette and alcohol consumption during the study

Who cannot join

  • Pregnant or nursing woman or planning a pregnancy during the study.
  • Subject with white or blond hair (coloured white hair also excluded to avoid affecting the PTG count);
  • Subject wearing a wig.
  • Subject with frizzy hair.
  • Subject having performed a hair bleaching or perm in the last 6 months or planned during the study.
  • Subject with modification of weight more than 5kg in the 2 months preceding the study and during the study, not using weight loss program or medication.
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  • Subject having performed a visit to sauna or hammam in the 2 weeks preceding the study
  • Subject having wounds, moles, tattoos, scars, irritated skin… in the test areas that could influence the study.
  • Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
  • Major subject who is under guardianship or who is not able to express his/her consent.
  • Subject in a social or sanitary establishment.
  • Subject suspected to be non-compliant according to the investigator's judgment.
  • France only: Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
  • Subject enrolled in another clinical trial or which exclusion period is not over.
  • Intensive exposure to sunlight or UV-rays 1 month before the study or planned during the study.
  • Subject employed at the study site.
  • Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
  • Subject suffering from a severe or progressive disease (AIDS, HIV-positive, infection hepatitis, insulin dependent diabetes mellitus, epilepsy, chronic gastrointestinal disease…) or any other pathology that may interfere with the evaluation of the study results and/or subject safety at the investigator appreciation.
  • Subject having history of severe allergy or anaphylactic shock.
  • Subject having history of diabetes (type I or type II)
  • Subject having antecedent of cancer.
  • Subject with known hypersensitivity or allergy to one of the components of the products.
  • Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
  • Subject having had surgery under general anaesthesia in the month preceding the start of the study.
  • 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.
  • Subject having skin disease on the head that requires actual topical medication or systemic drugs
  • Suffering from alopecia of special origins: chimiotherapy-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…), cicatricial alopecia, psychological disorders (trichotillomania, trichokryptomania).
  • Subject using minoxidil, finosteride, or other anti-hair loss treatment (including local hormonal treatment) within the past 6 months and during the study.
  • All other medical treatment (topic or per os) likely to interfere on hair growth or hair loss during the last 6 months prior the screening visit (including prostaglandins, rubefacients agents, all vasodilators, anti-androgens, all local hormonal treatment, silica, silicon, etc…);
  • Subject using anti-androgenic medications or drugs causing hypertrichosis (ex: phenytoin, acetazolamide, cyclosporine, diazoxide, psoralens, penicillamine, streptomycin, prostaglandins, vasodilatators and cortisone) or hypotrichosis (ex: anti-coagulants, retinoids, lithium and beta blockers) within the past 6 months and during the study.
  • Subject following a long period (>30 days) treatment of anti-inflammatory during the last 4 months before the start of the study (screening)
  • Subject using any product having an action on hair loss, an anti-dandruff effect, fortifying effect or an effect on hair weakness within the 2 weeks before the study and during the study (shampoo, conditioner, leave on product applied by friction). Styling products (gel, hairspray, etc) are allowed during the study except on visit days with phototrichogram measurements.
  • Subject taking food supplements (including vitamins and minerals) or other active compounds which may have an effect on hair, scalp, skin, nail, … 2 months prior to the start of the study and throughout the entire course of the study
  • Subject having had hair implants, surgical intervention or aesthetic procedure for capillary correction or intending to have recourse to this surgery during the study.
  • Subject with application of a treatment (oral or topical) with tretinoin or isotretinoin or corticosteroid 8 weeks prior to the start of the study and/or throughout the entire course of the study
  • Subject with systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) throughout the entire course of the study
  • Subject with systemic long-term therapy with anti-phlogistic agents or analgesics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study
  • Subjects using antibiotic medication within the 2 weeks before the study and during all the study duration

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • Eurofins Dermscan Pharmascan

    Aix-en-Provence, France, 13594

  • Eurofins EVIC

    Bordeaux, France, 33000

  • Eurofins Spincontrol

    Tours, France, 37000

  • Eurofins Dermscan Pharmascan

    Villeurbanne, France, 69100

Other trials in France

About this study

In order to validate the product performance, L'Oréal R\&I decided to conduct a new clinical study. The final product is intended to be performant in men and women. Therefore, L'Oréal R\&I wanted to conduct the clinical study on both these populations and compare the efficacy of the product to a placebo.

This clinical study aim is to collect data on Active Nutricosmetic performance and safety, for regulatory purposes. 240 subjects with hair loss, evaluated by phototrichogram (PTG), will be included and will use Active Nutricosmetic or Placebo for 6 months. A follow-up of hair loss (PTG), hair and scalp quality (mass, volume, shininess, fiber quality, sebum rate, diameter), subject satisfaction, illustration and product safety will be done 3 and 6 months after the treatment beginning.

Read the detailed description

Hair loss or alopecia is a common phenomenon that affects more than 80% of men and 50% of women during their lifetime. Alopecia is classified based on the cause and appearance and rarely by gender. Non-scaring (non-cicatricial) and scarring (cicatricial) alopecia are the two types of alopecia described. The non-cicatricial alopecia including Androgenetic alopecia (AGA), telogen effluvium (TE) or alopecia areata (AA) are the types of hair loss in which the hair follicles can typically resume normal activity when inflammatory process subsides. While, in scaring (cicatricial) alopecia the hair loss is irreversible and associated with pathologic conditions. AGA, an androgen-dependent hair loss is the common cause of hair loss and affects about 30-58% of men and approximatively 30% of middle-aged women. Even though alopecia does not often affect humans' global biological health, it has a negative impact on an individual's quality of life.

In order to propose an "in \& out" routine for hair care, L'Oréal R\&I decided to work on a dietary supplement formula for hair loss, hair growth, hair beauty and hair health. R\&I team focused on safety, regulatory compliance and performance to choose the socle of ingredients for this formula. As there were no active ingredient that met all three criteria, L'Oréal R\&I decided to adapt a previous socle of ingredients developed by INNEOV in 2013. As regulation and safety data have evolved between INNEOV was stopped and 2025, L'Oréal R\&I had to adapt the formula. This means that previous clinical data on the formula was not totally relevant and not applicable to the new formula.

The previous formula clinically studied by INNEOV in 2010-2015 was not anymore compliant with regulation, as these regulations have evolved and L'Oréal needs to launch the product on new countries, not taken in account by INNEOV. Moreover, there has been new data on dosage safety for some ingredients, leading to a decrease of dose compared to previous formulas. Some active ingredients were then decreased. As L'Oréal R\&I wanted to keep the efficacy as high as possible, other ingredients that were not present in the previous formulas have been added. These are mainly vitamins and minerals with authorized health claims.

Active nuricosmetic is co-developped in collaboration with dermatologists and nutritionists.

Active ingredients have been selected in order to improve hair and nail health and quality.

Taurine, L-cysteine and OPCs (oligomers of pro-anthocyanidins) of grape seed extract have been chosen to enhance microcirculation, consequently optimizing the supply of nutrients to hair and nail units.

In order to validate the product performance, L'Oréal R\&I decided to conduct a new clinical study. The final product is intended to be performant in men and women. Therefore, L'Oréal R\&I wanted to conduct the clinical study on both these populations and compare the efficacy of the product to a placebo.

This clinical study aim is to collect data on Active Nutricosmetic performance and safety, for regulatory purposes. 240 subjects with hair loss, evaluated by phototrichogram (PTG), will be included and will use Active Nutricosmetic or Placebo for 6 months. A follow-up of hair loss (PTG), hair and scalp quality (mass, volume, shininess, fiber quality, sebum rate, diameter), subject satisfaction, illustration and product safety will be done 3 and 6 months after the treatment beginning.

Conditions
Hair Loss
Being tested
Active nutricosmetic, Placebo Nutricosmetic
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active nutricosmeticDietary supplement

    Active ingredients have been selected in order to improve hair health and quality.

    Taurine, L-cysteine and oligomers of pro-anthocyanidins (OPCs) of grape seed extract have been chosen to enhance microcirculation, consequently optimizing the supply of nutrients to hair and nail units.

    Active Nutricosmetic is expected to provide beneficial effects on hair, such as hair growth, lower hair loss, shinier hair, stronger hair, increase of hair density.

  • Placebo NutricosmeticDietary supplement

    Placebo

Study groups in NCT07556016
Study groupRoleWhat they receive
Men in Active Nutricosmetic groupExperimentalMinimum 60 men in Active Nutricosmetic group
Receives: Dietary Supplement: Active nutricosmetic
men in Placebo Nutricosmetic groupPlacebo comparatorMinimum 60 men in Placebo Nutricosmetic group
Receives: Dietary Supplement: Placebo Nutricosmetic
women in Active Nutricosmetic groupExperimentalMinimum 60 women in Active Nutricosmetic group
Receives: Dietary Supplement: Active nutricosmetic
women in Placebo Nutricosmetic groupPlacebo comparatorMinimum 60 women in Placebo Nutricosmetic group
Receives: Dietary Supplement: Placebo Nutricosmetic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total hair density on global population

    Change from baseline between Active and Placebo Nutricosmetic groups (global population) in the total hair density (DE), evaluated by phototrichogram (PTG) method at Month6 (6 months of use).

    Measured: Month 6 / Day 0

Secondary outcomes (22)
  1. total hair density

    Change from baseline between Active and Placebo Nutricosmetic groups in the total hair density (DE), evaluated by phototrichogram (PTG) method at Month 3 (3 months of use).

    Measured: Month 3, Day 0

  2. total hair density on men and women population

    Change from baseline between Active and Placebo Nutricosmetic groups in the total hair density (DE), evaluated by phototrichogram (PTG) method (in men and in women) at Month 6 (6 months of use).

    Measured: Month 6 / Day 0

  3. PTG parameter : telogen hair

    Change from baseline between Active and Placebo Nutricosmetic groups of the following PTG parameter at Month 3 and Month 6: percentage of telogen hair (%T)

    Measured: Month 6 / Month 3 / Day 0

  4. PTG parameter : anagen hair density

    Change from baseline between Active and Placebo Nutricosmetic groups of the following PTG parameter at Month 3 and Month 6: anagen hair density (DA)

    Measured: Month 6 / Month 3 / Day 0

  5. PTG parameter : telogen hair density

    Change from baseline between Active and Placebo Nutricosmetic groups of the following PTG parameter at Month 3 and Month 6: telogen hair density (DT)

    Measured: Month 6 / Month 3 / Day 0

  6. PTG parameter : anagen to telogen ratio (DA/DT)

    Change from baseline between Active and Placebo Nutricosmetic groups of the following PTG parameter at Month 3 and Month 6: anagen to telogen ratio (DA/DT)

    Measured: Month 6 / Month 3 / Day 0

  7. PTG parameter : hair diameter

    Change from baseline between Active and Placebo Nutricosmetic groups of the following PTG parameter at Month 3 and Month 6: hair diameter

    Measured: Month 6 / Month 3 / Day 0

  8. Clinical score : hair mass

    Change from baseline between Active and Placebo Nutricosmetic groups of the following clinical scored parameters at Month 3 and Month 6: hair mass scored by expert grader using a 10-point scale.

    Measured: Month 6 / Month 3 / Day 0

  9. Clinical score : hair volume

    Change from baseline between Active and Placebo Nutricosmetic groups of the following clinical scored parameters at Month 3 and Month 6: hair volume ascored by expert grader using a 10-point scale.

    Measured: Month 6 / Month 3 / Day 0

  10. Clinical score : hair shine

    Change from baseline between Active and Placebo Nutricosmetic groups of the following clinical scored parameters at Month 3 and Month 6: hair shine scored by expert grader using a 10-point scale.

    Measured: Month 6 / Month 3 / Day 0

  11. Scalp sebum rate

    Change from baseline between Active and Placebo Nutricosmetic groups of scalp sebum rate, measured with Sebumeter® at M3 and M6

    Measured: Month 6 / Month 3 / Day 0

  12. Hair sampling : flexion

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Minth 6 measured on hair sampling: flexion

    Measured: Month 6 / Day 0

  13. Hair sampling : friction

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 6 measured on hair sampling: friction

    Measured: Month 6 / Day 0

  14. Hair sampling : traction

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 6 measured on hair sampling: traction

    Measured: Month 6 / Day 0

  15. Hair sampling : breakage

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at M6 measured on hair sampling: breakage

    Measured: Month 6 / Day 0

  16. Scalp Reader: hair diameter

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 3 and Month 6 measured by Scalp reader: hair diameter in um

    Measured: Month 6 / Month 3 / Day 0

  17. Scalp Reader: hair follicle miniaturization

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 3 and Month 6 measured by Scalp reader: hair follicle miniaturization from 0 to 100%

    Measured: Month 6 / Month 3 / Day 0

  18. Scalp Reader: hair density

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 3 and Month 6 measured by Scalp reader: hair density from 0 to 100

    Measured: Month 6 / Month 3 / Day 0

  19. Scalp Reader : scalp microbiome indicator

    Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 3 and Month 6 measured by Scalp reader: scalp microbiome indicator.

    Measured: Month 6 / Month 3 / Day 0

  20. Hair microbiome

    Description on Active and Placebo Nutricosmetic groups at Day 0 and Month 6 of scalp microbiome (scalp swabbing): sequencing and species quantifications

    Measured: Month 6 / Day 0

  21. Subject satisfaction

    Evaluation of the subject satisfaction using a subjective evaluation questionnaire completed by the subjects at Month 3 and Month 6. Answers will be compared within groups and between active and placebo nutricosmetic groups.

    Measured: Month 6 / Month 3

  22. Tolerance

    Collection of adverse events (AE) and concomitant treatments throughout the study and global tolerance interpretation

    Measured: Month 6 / Month 3 / Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start4 Nov 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556016
Sponsor's protocol ID
25-1200-U5 / VCY25-008
Status last verified
Apr 2026
First submitted
14 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active nutricosmetic in people with Hair Loss, run by L'Oreal at 4 sites 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 23 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total hair density on global population (time frame: Month 6 / Day 0). 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 29 Apr 2026.

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