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. 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.STOUGH D, 2007, J COSMET DERMATOL, V6, P9Olsen EA, 2006, J AM ACAD DERMATOL, V55, P1014, DOI 10.1016/j.jaad.2006.05.007Olsen EA, 2005, J AM ACAD DERMATOL, V52, P301, DOI 10.1016/j.jaad.2004.04.008OLSZEWSKA M, 2005, J DRUGS DERMATOL, V4, P637Debruyne F, 2004, EUR UROL, V46, P488, DOI 10.1016/j.eururo.2004.05.008Clark RV, 2004, J CLIN ENDOCR METAB, V89, P2179, DOI 10.1210/jc.2003-030330Roehrborn CG, 2004, UROLOGY, V63, P709, DOI 10.1016/j.urology.2004.01.001Price VH, 1999, NEW ENGL J MED, V341, P964Kaufman KD, 1998, J AM ACAD DERMATOL, V39, P578Bramson HN, 1997, J PHARMACOL EXP THER, V282, P1496Canfield D, 1996, DERMATOL CLIN, V14, P713Courtois M, 1996, BRIT J DERMATOL, V134, P47DALLOB AL, 1994, J CLIN ENDOCR METAB, V79, P703RUSSELL DW, 1994, ANNU REV BIOCHEM, V63, P25OLSEN EA, 1994, DISORDERS HAIR GROWT, P257THIGPEN AE, 1993, J CLIN INVEST, V92, P903CASH TF, 1992, J AM ACAD DERMATOL, V26, P926JENKINS EP, 1992, J CLIN INVEST, V89, P293RANDALL VA, 1991, BRIT J DERMATOL, V124, P146NORWOOD OT, 1975, SOUTHERN MED J, V68, P1359IMPERATO.J, 1974, SCIENCE, V186, P1213HAMILTON JB, 1951, ANN NY ACAD SCI, V53, P708