Assessment of the efficacy of a new formulation of minoxidil (DC120) on hair growth, in a minizone model in androgenetic alopecia in men

Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)0 个研究点开始时间: 2015年4月10日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•- Male aged from 18 to 65 years old
•- Androgenetic alopecia on fronto-temporal areas (Norwood/Hamilton grade 3/3a, 3V to 4/4a)
•- Phototype I to IV according to Fitzpatrick’s classification.
•Ethical /legal considerations:
•- Having signed the written informed consent (V0)
•- Accepting to have 2 shaved and tattooed minizones on the scalp;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 220
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Other known causes of alopecia (alopecia areata, hair loss related to endocrinopathies, telogen effluvium …);
•- Any scalp abnormality, inflammation or disease processes in the skin including excoriation, psoriasis and sunburn; or any underlying conditions on the investigational areas that may interfere with the alopecia evaluation or favour product absorption;
•- Shaved scalp
•- History of surgery on the investigational scalp areas (e.g. hair transplant)
•- Known hypersensitivity to minoxidil or any of the excipients;
•- Minoxidil: within the last 3 months prior to V0 and during the study duration,
•- Hair loss treatments within the last 3 months prior to V0 and during the study duration,
•- Known cardiovascular disease, cardiopathy or cardiac arrhythmia
•- Tachycardia;
•- Treated or untreated hypertension;
•- History of hypotension;

发起方

Pierre Fabre Dermatologie represented by the Institut de Recherche Pierre Fabre (IRPF)