Status:
NOT_YET_RECRUITING
Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss
Lead Sponsor:
Cosmetique Active International
Collaborating Sponsors:
Centre Hospitalier Universitaire de Nice
Saint-Louis Hospital, Paris, France
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
18-41 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06590779
Start Date
November 2 2024
End Date
May 2 2026
Last Update
September 19 2024
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