Original articleA randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia
Section snippets
Study design
This was a randomized, double-blind, double-dummy, parallel-group, 29-week study conducted at 39 centers (academic and private) in 9 countries (Argentina, Chile, Japan, Mexico, Philippines, Peru, Russian Federation, Taiwan, and Thailand). A screening period (up to 3 weeks) was followed by 24 weeks of treatment and a 2-week follow-up period (Clinicaltrials.gov identifier: NCT01231607).
Patients were randomized (1:1:1:1:1 ratio) to dutasteride 0.02, 0.1, or 0.5 mg/d; finasteride 1 mg/d; or matched
Results
Fig 1 shows subject disposition throughout the study (October 2010 to February 2012). The intent-to-treat population contained 917 patients, of which 761 completed the study. Subject demographics and baseline characteristics were similar across treatment groups (Table I). Ninety percent of subjects were compliant with their study treatment (assessed by pill count), taking 75% to 125% of their assigned study drug.
Discussion
In this study, dutasteride 0.5 mg was statistically superior to finasteride 1 mg and placebo, whereas finasteride was superior to placebo, at increasing hair count and width after 24 weeks of treatment in men with androgenetic alopecia. These results are consistent with another phase III trial, in which dutasteride 0.5 mg significantly increased hair count at week 24 versus placebo.24 Although dutasteride 0.5 mg significantly increased hair count versus placebo at 12 and 24 weeks in a phase II
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Cited by (0)
Medical writing support in the development of this manuscript was provided by Kerri Bridgwater, BSc, Choice Healthcare Solutions, Hitchin, United Kingdom, and funded by GlaxoSmithKline.
Disclosure: Dr Gubelin Harcha has served as an investigator for GlaxoSmithKline. Dr Tsai has served as a speaker and an advisory board member for GlaxoSmithKline and Stiefel (currently GlaxoSmithKline), and as an investigator for Merck Sharp and Dohme. Dr Kawashima has served as an external medical advisor for GlaxoSmithKline. Ms Barnes and Drs Chetty and Ferron-Brady are employees of and own stock in GlaxoSmithKline. Drs Barboza Martínez, Katsuoka, and Tsuboi have no conflicts of interest to declare.