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

Eun, Hee Chul; Kwon, Oh Sang; Yeon, Je Ho; Shin, Hyo Seung; Kim, Byung Yoon; Ro, Byung In; Cho, Han Kyong; Sim, Woo Young; Lew, Bark Lynn; Lee, Won-Soo; Park, Hwa Young; Hong, Seung Phil; Ji, Jae Hong

doi:10.1016/j.jaad.2009.09.018

« Previous Next »Journal of the American Academy of Dermatology
Volume 63, Issue 2 , Pages 252-258, August 2010

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

Hee Chul Eun, MD
- Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea
- Reprint requests: Hee Chul Eun, MD, Department of Dermatology, Seoul National University College of Medicine, Seoul National University Hospital, 101, Daehang-ro, Jongno-gu, Seoul, 110-744 Korea.
Oh Sang Kwon, MD
- Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea
Je Ho Yeon, MD
- Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea
Hyo Seung Shin, MD
- Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea
Byung Yoon Kim, MD
- Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea
Byung In Ro, MD
- Department of Dermatology, Kwandong University College of Medicine, Koyang, Kyunggi, Korea
Han Kyong Cho, MD
- Department of Dermatology, Kwandong University College of Medicine, Koyang, Kyunggi, Korea
Woo Young Sim, MD
- Department of Dermatology, College of Medicine, Kyong Hee University, Seoul, Korea
Bark Lynn Lew, MD
- Department of Dermatology, College of Medicine, Kyong Hee University, Seoul, Korea
Won-Soo Lee, MD
- Department of Dermatology, Yonsei University Wonju College of Medicine, Wonju, Korea
- Institute of Hair and Cosmetic Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
Hwa Young Park, MD
- Department of Dermatology, Yonsei University Wonju College of Medicine, Wonju, Korea
Seung Phil Hong, MD
- Department of Dermatology, Yonsei University Wonju College of Medicine, Wonju, Korea
Jae Hong Ji, MD
- Department of Dermatology, Yonsei University Wonju College of Medicine, Wonju, Korea

Accepted 8 September 2009. published online 04 June 2010.

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/cm² in dutasteride group and 4.7/cm² 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.

Key words: androgenetic alopecia, dutasteride, male pattern hair loss, treatment

Abbreviations used: 5AR, 5 alpha reductase, DHT, dihydrotestosterone, HGI, hair growth index, MPHL, male pattern hair loss