Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male
patients with male pattern hair loss: a randomized, double-blind,
placebo-controlled, phase III study.
Author(s): Eun HC, Kwon OS, Yeon JH, Shin HS, Kim BY, Ro BI, Cho HK, Sim WY, Lew BL, Lee WS,
Park HY, Hong SP, Ji JH.
Affiliation(s): Department of Dermatology, Seoul National University College of Medicine, Seoul,
Korea. hceun@snu.ac.kr
Publication date & source: 2010, J Am Acad Dermatol. , 63(2):252-8
BACKGROUND: Dutasteride (Avodart) is a dual inhibitor of both type I and type II
5 alpha reductases, and thus inhibits conversion of testosterone to
dihydrotestosterone, a key mediator of male pattern hair loss.
OBJECTIVES: The aim of this randomized double-blind phase III study was to
compare the efficacy, safety, and tolerability of dutasteride (0.5 mg) and
placebo for 6 months of treatment in male patients with male pattern hair loss.
METHODS: A total of 153 men, 18 to 49 years old, were randomized to receive 0.5
mg of dutasteride or placebo daily for 6 months. Efficacy was evaluated by the
change of hair counts, subject assessment, and photographic assessment by
investigators and panels.
RESULTS: Mean change of hair counts from baseline to 6 months after treatment
start was an increase of 12.2/cm(2) in dutasteride group and 4.7/cm(2) in placebo
group and this difference was statistically significant (P = .0319). Dutasteride
showed significantly higher efficacy than placebo group by subject
self-assessment and by investigator and panel photographic assessment. There was
no major difference in adverse events between two groups.
LIMITATIONS: The study was limited to 6 months.
CONCLUSIONS: This study clearly showed that 0.5 mg of dutasteride improved hair
growth and was relatively well tolerated for the treatment of male pattern hair
loss.
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