Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss
ConditionAndrogenetic Alopecia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-41
SponsorCosmetique Active International
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Aminexil® active+ lotion
Other interventionAminexil® active+ lotion
Finasteride 1mg
Other interventionFinasteride 1 mg
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Finasteride 1 mg & Aminexil® active+ lotionExperimental treatment 2 interventions
Group B: Finasteride 1 mgActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Time frame
baseline T02
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Time frame
Day 33
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Time frame
Day 844
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Time frame
Day 86Secondary outcomes
1
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Time frame
baseline Day 12
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Time frame
Day 843
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Time frame
Day 1684
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Time frame
Day 336Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cosmetique Active International
Lead sponsor
Centre Hospitalier Universitaire de Nice
Collaborator
Saint-Louis Hospital, Paris, France
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: