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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hair Loss
• Intervention / Treatment: Dietary supplement: Active nutricosmetic; Dietary supplement: Placebo Nutricosmetic

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.

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Aix-en-Provence, France, France, 13594
      • Eurofins Dermscan Pharmascan
    • Bordeaux, France, France, 33000
      • Eurofins EVIC
    • Tours, France, France, 37000
      • Eurofins Spincontrol
    • Villeurbanne, France, France, 69100
      • Eurofins Dermscan Pharmascan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Men in Active Nutricosmetic group; Minimum 60 men in Active Nutricosmetic group	Dietary supplement: Active nutricosmetic; 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 Comparator: men in Placebo Nutricosmetic group; Minimum 60 men in Placebo Nutricosmetic group	Dietary supplement: Placebo Nutricosmetic; Placebo
Experimental: women in Active Nutricosmetic group; Minimum 60 women in Active Nutricosmetic group	Dietary supplement: Active nutricosmetic; 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 Comparator: women in Placebo Nutricosmetic group; Minimum 60 women in Placebo Nutricosmetic group	Dietary supplement: Placebo Nutricosmetic; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 6 / Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 3, Day 0
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).	Month 6 / Day 0
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)	Month 6 / Month 3 / Day 0
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)	Month 6 / Month 3 / Day 0
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)	Month 6 / Month 3 / Day 0
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)	Month 6 / Month 3 / Day 0
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	Month 6 / Month 3 / Day 0
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.	Month 6 / Month 3 / Day 0
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.	Month 6 / Month 3 / Day 0
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.	Month 6 / Month 3 / Day 0
Scalp sebum rate	Change from baseline between Active and Placebo Nutricosmetic groups of scalp sebum rate, measured with Sebumeter® at M3 and M6	Month 6 / Month 3 / Day 0
Hair sampling : flexion	Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Minth 6 measured on hair sampling: flexion	Month 6 / Day 0
Hair sampling : friction	Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 6 measured on hair sampling: friction	Month 6 / Day 0
Hair sampling : traction	Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at Month 6 measured on hair sampling: traction	Month 6 / Day 0
Hair sampling : breakage	Change from baseline between Active and Placebo Nutricosmetic groups of the following parameters at M6 measured on hair sampling: breakage	Month 6 / Day 0
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	Month 6 / Month 3 / Day 0
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%	Month 6 / Month 3 / Day 0
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	Month 6 / Month 3 / Day 0
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.	Month 6 / Month 3 / Day 0
Hair microbiome	Description on Active and Placebo Nutricosmetic groups at Day 0 and Month 6 of scalp microbiome (scalp swabbing): sequencing and species quantifications	Month 6 / Day 0
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.	Month 6 / Month 3
Tolerance	Collection of adverse events (AE) and concomitant treatments throughout the study and global tolerance interpretation	Month 6 / Month 3 / Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scalp Reader and PTG	Statistical correlation between Scalp diagnosis parameter (with Scalp reader) and PTG methods on these 3 parameters on global population: DE Total density (PTG) / Hair density (Scalp reader); Hair diameter (PTG) / Hair diameter (Scalp reader); Standard deviation of Hair diameter (PTG) / Hair diameter diversity (Scalp reader)	Month 6 / Day 0
Scalp Reader and Microbiome	Statistical correlation between Scalp diagnosis method (with Scalp reader) and microbiome analysis (SWAB) on: • Scalp microbiome indicator (Scalp reader) / Scalp microbiome analyzis (C. acnes and qPCR)	Month 6 / Day 0

Collaborators and Investigators

• Sponsor: L'Oreal

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia
• Other Study ID Numbers: 25-1200-U5 / VCY25-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No