Clinical trial NCT06590779: Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss
Official title: Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Universitaire de Nice
name: Saint-Louis Hospital, Paris, France
First posted: 2024-09-19
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Finasteride 1mg Arm 2: Finasteride 1mg + Aminexil® active+ lotion
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Phototrichogram
timeFrame: baseline T0
measure: Phototrichogram
timeFrame: Day 3
measure: Phototrichogram
timeFrame: Day 84
measure: Phototrichogram
timeFrame: Day 86
measure: Phototrichogram
timeFrame: Day 168
measure: Phototrichogram
timeFrame: Day 170
measure: Phototrichogram
timeFrame: Day 336
measure: Phototrichogram
timeFrame: Day 338
Secondary outcomes:
measure: Scalp coverage evaluation
timeFrame: baseline Day 1
measure: Scalp coverage evaluation
timeFrame: Day 84
measure: Scalp coverage evaluation
timeFrame: Day 168
measure: Scalp coverage evaluation
timeFrame: Day 336
measure: Subject Evaluation on Vertex and Frontal Area of hair quality
timeFrame: baseline Day 1
measure: Subject Evaluation on Vertex and Frontal Area of hair quality
timeFrame: Day 84
measure: Subject Evaluation on Vertex and Frontal Area of hair quality
timeFrame: Day 168
measure: Subject Evaluation on Vertex and Frontal Area of hair quality
timeFrame: Day 252
measure: Subject Evaluation on Vertex and Frontal Area of hair quality
timeFrame: Day 336
measure: Quality of life assessment
timeFrame: baseline Day 1
measure: Quality of life assessment
timeFrame: Day 84
measure: Quality of life assessment
timeFrame: Day 168
measure: Quality of life assessment
timeFrame: Day 336
measure: Local discomfort
timeFrame: baseline Day 1
measure: Local discomfort
timeFrame: Day 84
measure: Local discomfort
timeFrame: Day 168
measure: Local discomfort
timeFrame: Day 336
measure: Local reactions
timeFrame: baseline Day 1
measure: Local reactions
timeFrame: Day 84
measure: Local reactions
timeFrame: Day 168
measure: Local reactions
timeFrame: Day 336
measure: Adverse events
timeFrame: baseline Day 1
measure: Adverse events
timeFrame: baseline Day 3
measure: Adverse events
timeFrame: Day 42
measure: Adverse events
timeFrame: Day 84
measure: Adverse events
timeFrame: Day 86
measure: Adverse events
timeFrame: Day 126
measure: Adverse events
timeFrame: Day 168
measure: Adverse events
timeFrame: Day 170
measure: Adverse events
timeFrame: Day 210
measure: Adverse events
timeFrame: Day 252
measure: Adverse events
timeFrame: Day 294
measure: Adverse events
timeFrame: Day 336
measure: Adverse events
timeFrame: Day 338
Other outcomes:
Locations:
Study officials:
References: