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

NCT06590779 | Not Yet Recruiting

• 1 other identifier: VCY23-015
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (8)

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  baseline T0

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 3

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 84

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 86

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 168

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 170

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 336

• Phototrichogram

  photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles

  Day 338

Secondary Outcomes (34)

• Scalp coverage evaluation

  baseline Day 1

• Scalp coverage evaluation

  Day 84

• Scalp coverage evaluation

  Day 168

• Scalp coverage evaluation

  Day 336

• Subject Evaluation on Vertex and Frontal Area of hair quality

  baseline Day 1

Study Arms (2)

Finasteride 1 mg & Aminexil® active+ lotion

EXPERIMENTAL

Administration of Finasteride 1 mg + Aminexil® active+ lotion

Other: Aminexil® active+ lotion; Other: Finasteride 1mg

Finasteride 1 mg

ACTIVE COMPARATOR

Administration of Finasteride 1 mg

Other: Finasteride 1mg

Interventions

Aminexil® active+ lotion OTHER

Aminexil® active+ lotion

Finasteride 1 mg & Aminexil® active+ lotion

Finasteride 1mg OTHER

Finasteride 1 mg

Finasteride 1 mg; Finasteride 1 mg & Aminexil® active+ lotion

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cosmetique Active International: lead
• Centre Hospitalier Universitaire de Nice: collaborator
• Saint-Louis Hospital, Paris, France: collaborator

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Central Study Contacts

Julie Faure

CONTACT

33049643274; julie.faure@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator blinded, randomised study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Finasteride 1mg Arm 2: Finasteride 1mg + Aminexil® active+ lotion

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: November 2, 2024
• Primary Completion: December 2, 2025
• Study Completion: May 2, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share