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.
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.


OBJECTIVE
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.


CONCLUSIONS
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.
Eun
Hee Chul
HC
Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea. hceun@snu.ac.kr
Kwon
Oh Sang
OS
Yeon
Je Ho
JH
Shin
Hyo Seung
HS
Kim
Byung Yoon
BY
Ro
Byung In
BI
Cho
Han Kyong
HK
Sim
Woo Young
WY
Lew
Bark Lynn
BL
Lee
Won-Soo
WS
Park
Hwa Young
HY
Hong
Seung Phil
SP
Ji
Jae Hong
JH
D000293:Adolescent; D000328:Adult; D000505:Alopecia / Q000188:drug therapy*; D001378:Azasteroids / Q000008:administration & dosage* / Q000009:adverse effects; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006197:Hair / Q000187:drug effects* / Q000254:growth & development*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010781:Photography; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
D001378:Azasteroids; D004791:Enzyme Inhibitors; D010919:Placebos; D000068538:Dutasteride