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 - 14/02/14
, Julia Barboza Martínez, MD b, Tsen-Fang Tsai, MD c, Kensei Katsuoka, MD d, Makoto Kawashima, MD, PhD e, Ryoji Tsuboi, MD, PhD f, Allison Barnes, MS g, Geraldine Ferron-Brady, PharmD, PhD h, Dushen Chetty, PhD iAbstract |
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.
Il testo completo di questo articolo è disponibile in PDF.Key words : 5-alpha reductase, 5-alpha reductase inhibitors, androgenetic alopecia, dutasteride, finasteride, male pattern baldness, male pattern hair loss, treatment
Abbreviations used : 5AR, 5ARI, AE, HGI, HGSS, IPAQ, SAE
Mappa
| 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. |
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| 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. |
Vol 70 - N° 3
P. 489 - marzo 2014 Ritorno al numero
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