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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.
J Am Acad Dermatol. 2014 Mar; 70(3):489-498.e3.JA

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.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24411083

Citation

Gubelin Harcha, Walter, et al. "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." Journal of the American Academy of Dermatology, vol. 70, no. 3, 2014, pp. 489-498.e3.
Gubelin Harcha W, Barboza Martínez J, Tsai TF, et al. 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. J Am Acad Dermatol. 2014;70(3):489-498.e3.
Gubelin Harcha, W., Barboza Martínez, J., Tsai, T. F., Katsuoka, K., Kawashima, M., Tsuboi, R., Barnes, A., Ferron-Brady, G., & Chetty, D. (2014). 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. Journal of the American Academy of Dermatology, 70(3), 489-e3. https://doi.org/10.1016/j.jaad.2013.10.049
Gubelin Harcha W, et al. 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. J Am Acad Dermatol. 2014;70(3):489-498.e3. PubMed PMID: 24411083.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Gubelin Harcha,Walter, AU - Barboza Martínez,Julia, AU - Tsai,Tsen-Fang, AU - Katsuoka,Kensei, AU - Kawashima,Makoto, AU - Tsuboi,Ryoji, AU - Barnes,Allison, AU - Ferron-Brady,Geraldine, AU - Chetty,Dushen, Y1 - 2014/01/09/ PY - 2013/07/15/received PY - 2013/10/24/revised PY - 2013/10/27/accepted PY - 2014/1/14/entrez PY - 2014/1/15/pubmed PY - 2014/4/12/medline KW - 5-alpha reductase KW - 5-alpha reductase inhibitors KW - androgenetic alopecia KW - dutasteride KW - finasteride KW - male pattern baldness KW - male pattern hair loss KW - treatment SP - 489 EP - 498.e3 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 70 IS - 3 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/24411083/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_ DB - PRIME DP - Unbound Medicine ER -