Original article
A 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

https://doi.org/10.1016/j.jaad.2013.10.049Get rights and content

Background

Dihydrotestosterone is the main androgen causative of androgenetic alopecia, a psychologically and physically harmful condition warranting medical treatment.

Objective

We sought to compare the efficacy and safety of dutasteride (type 1 and 2 5-alpha reductase inhibitor) with finasteride (type 2 5-alpha reductase inhibitor) and placebo in men with androgenetic alopecia.

Methods

Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride (0.02, 0.1, or 0.5 mg/d), finasteride (1 mg/d), or placebo for 24 weeks. The primary end point was hair count (2.54-cm diameter) at week 24. Other assessments included hair count (1.13-cm diameter) and width, photographic assessments (investigators and panel), change in stage, and health outcomes.

Results

In total, 917 men were randomized. Hair count and width increased dose dependently with dutasteride. Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth (frontal view; panel photographic assessment) at week 24 compared with finasteride (P = .003, P = .004, and P = .002, respectively) and placebo (all P < .001). The number and severity of adverse events were similar among treatment groups.

Limitations

The study was limited to 24 weeks.

Conclusions

Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated.

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.

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