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

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new cosmetic lotion developed by Vichy that aims to help men experiencing hair loss due to androgenetic alopecia, commonly known as male pattern baldness. The trial will compare the effectiveness of this lotion combined with a medication called finasteride to using finasteride alone. Researchers want to see how well this combination works in promoting hair growth in men aged 18 to 41 who have a specific level of hair loss.

To participate, men must have light to dark brown hair and a certain type of skin. They should have some hair loss that fits within a defined range and must agree to keep their hair at a certain length throughout the study. Participants will also need to avoid hair treatments like dyeing or perming their hair during the trial. If eligible, participants can expect to have regular assessments to measure hair growth and will be closely monitored by the study team. It's important to note that certain health conditions or prior treatments may exclude individuals from joining.

Gender

MALE

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;