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J Am Acad Dermatol. 2014 Mar;70(3):489-498.e3. doi: 10.1016/j.jaad.2013.10.049. Epub 2014 Jan 9.

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.

Author information

1
Centro Médico Skinmed and Universidad de los Andes, Santiago, Chile. Electronic address: wgubelin@skinmed.cl.
2
Unidad de Investigación, Clínica Internacional, Lima, Peru.
3
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
4
Department of Dermatology, Kitasato University, Tokyo, Japan.
5
Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
6
Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
7
GlaxoSmithKline Research & Development, Research Triangle Park, North Carolina.
8
GlaxoSmithKline Research & Development, King of Prussia, Pennsylvania.
9
GlaxoSmithKline Research & Development, Singapore.

Abstract

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.

KEYWORDS:

5-alpha reductase; 5-alpha reductase inhibitors; androgenetic alopecia; dutasteride; finasteride; male pattern baldness; male pattern hair loss; treatment

PMID:
24411083
DOI:
10.1016/j.jaad.2013.10.049
[Indexed for MEDLINE]

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