Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss

NCT ID: NCT06590779

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-02
• Study Completion Date: 2026-05-02

Brief Summary

Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.

Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.

The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Finasteride 1 mg & Aminexil® active+ lotion

Administration of Finasteride 1 mg + Aminexil® active+ lotion

Group Type: EXPERIMENTAL

Aminexil® active+ lotion

Intervention Type: OTHER

Aminexil® active+ lotion

Finasteride 1mg

Intervention Type: OTHER

Finasteride 1 mg

Finasteride 1 mg

Administration of Finasteride 1 mg

Group Type: ACTIVE_COMPARATOR

Finasteride 1mg

Intervention Type: OTHER

Finasteride 1 mg

Interventions

Aminexil® active+ lotion

Aminexil® active+ lotion

Intervention Type: OTHER

Finasteride 1mg

Finasteride 1 mg

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male subject aged 18-41 years old with skin type I to IV according to the Fitzpatrick scale;
• Affected by androgenetic alopecia with hair loss evaluated grade IIA to IV the modified Norwood-Hamilton scale;
• Subject with chestnut brown, dark or black hair;
• Subject with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
• Subject agreeing to have a shaved zone of 1.5 cm² on scalp area;
• Subject accepting not to dye, bleach his hair or to do a permanent wave during the whole study duration;
• Subject accepting to use condoms if her partner is pregnant.

Exclusion Criteria

• Female subject;
• Subject presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
• Subjects suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies), seasonal hair loss;
• Subject having any other concomitant dermatological affection of the scalp (psoriasis, seborrheic dermatitis, eczema, other alopecia than androgenetic);
• Subject suffering from a recurrent, acute, non-stabilized or evolving disease judged by the investigator able to interfere with the study needs and hair growth;
• Subject having had surgical intervention for capillary correction (e.g., hair transplant) or intending to have recourse to this surgery during the entire study period;
• Subject presenting a hypersensitivity to any of the components of the finasteride medication or to any 5-alpha-reductase inhibitor;
• Subject that has applied or taken prior to the start of the study (screening) interfering drugs or products
• Subject 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;
• Subject following a long period (>30 days) treatment of anti-inflammatory within 4 months prior to the start of the study (screening visit);
• Subject taking topic cosmetic treatment or per os nutritional supplement likely to interfere on hair growth or hair loss during the last 3 months prior to the screening visit;
• Subject having a topical or oral route treatment of the scalp (anti-seborrheic, anti-dandruff, daily friction) within 2 weeks prior to the screening visit;
• Subject 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;
• Subject having a wig or hair extension;
• Protected subject 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;
• Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function;
• Subject currently participating in another clinical study or being in an exclusion period of another clinical study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role: collaborator

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Julie Faure

Role: CONTACT

julie.faure@loreal.com

33049643274

Other Identifiers

VCY23-015

Identifier Type: -

Identifier Source: org_study_id