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

L'Oreal

Status: Active, not recruiting

Conditions: Hair Loss

Treatments: Dietary Supplement: Active nutricosmetic; Dietary Supplement: Placebo Nutricosmetic

Study type: Interventional

Funder types: Industry

Identifiers

NCT07556016

25-1200-U5 / VCY25-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 4 patient groups, including a placebo group

Men in Active Nutricosmetic group

Experimental group

Description:

Minimum 60 men in Active Nutricosmetic group

Treatment:

Dietary Supplement: Active nutricosmetic

men in Placebo Nutricosmetic group

Placebo Comparator group

Description:

Minimum 60 men in Placebo Nutricosmetic group

Treatment:

Dietary Supplement: Placebo Nutricosmetic

women in Active Nutricosmetic group

Experimental group

Description:

Minimum 60 women in Active Nutricosmetic group

Treatment:

Dietary Supplement: Active nutricosmetic

women in Placebo Nutricosmetic group

Placebo Comparator group

Description:

Minimum 60 women in Placebo Nutricosmetic group

Treatment:

Dietary Supplement: Placebo Nutricosmetic