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

NCT07556016 | Active Not Recruiting

• 1 other identifier: 25-1200-U5 / VCY25-008
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 4

Brief 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. 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

Outcome Measures

Primary Outcomes (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).

  Month 6 / Day 0

Secondary Outcomes (22)

• total hair density

  Month 3, Day 0

• total hair density on men and women population

  Month 6 / Day 0

• PTG parameter : telogen hair

  Month 6 / Month 3 / Day 0

• PTG parameter : anagen hair density

  Month 6 / Month 3 / Day 0

• PTG parameter : telogen hair density

  Month 6 / Month 3 / Day 0

Other Outcomes (2)

• Scalp Reader and PTG

  Month 6 / Day 0

• Scalp Reader and Microbiome

  Month 6 / Day 0

Study Arms (4)

Men in Active Nutricosmetic group

EXPERIMENTAL

Minimum 60 men in Active Nutricosmetic group

Dietary Supplement: Active nutricosmetic

men in Placebo Nutricosmetic group

PLACEBO COMPARATOR

Minimum 60 men in Placebo Nutricosmetic group

Dietary Supplement: Placebo Nutricosmetic

women in Active Nutricosmetic group

EXPERIMENTAL

Minimum 60 women in Active Nutricosmetic group

Dietary Supplement: Active nutricosmetic

women in Placebo Nutricosmetic group

PLACEBO COMPARATOR

Minimum 60 women in Placebo Nutricosmetic group

Dietary Supplement: Placebo Nutricosmetic

Interventions

Active nutricosmetic DIETARY_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.

Men in Active Nutricosmetic group; women in Active Nutricosmetic group

Placebo Nutricosmetic DIETARY_SUPPLEMENT

Placebo

men in Placebo Nutricosmetic group; women in Placebo Nutricosmetic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Intensive exposure to sunlight or UV-rays 1 month before the study or planned during the study.
• Subject employed at the study site.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (4)

Eurofins Dermscan Pharmascan

Aix-en-Provence, France, 13594, France

Location

Eurofins EVIC

Bordeaux, France, 33000, France

Location

Eurofins Spincontrol

Tours, France, 37000, France

Location

Eurofins Dermscan Pharmascan

Villeurbanne, France, 69100, France

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)