Walter Gubelin Harcha1, Julia Barboza Martínez2, Tsen-Fang Tsai3, Kensei Katsuoka4, Makoto Kawashima5, Ryoji Tsuboi6, Allison Barnes7, Geraldine Ferron-Brady8, Dushen Chetty9. 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.
RCT Entities:
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.
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