Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Last updated: June 18, 2018
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Scalp Disorders

Hair Loss

Alopecia

Treatment

N/A

Clinical Study ID

NCT01231607
114263
  • Ages 20-50
  • Male

Study Summary

The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Norwood-Hamilton Type III vertex, IV, or V

Exclusion

Exclusion Criteria:

  • History or evidence of hair loss other than androgenetic alopecia

  • Scarring of the scalp

  • Use of dutasteride in previous 18 months

  • Use of finasteride within previous 12 months

  • Hair transplantation or hair weaving within 6 months

  • Use of Minoxidil within previous 6 months

  • Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months

  • Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months

  • Light or laser treatment of scalp within previous 3 months

  • Cosmetic products aimed at improving or correcting signs of hair loss within previous 2 weeks

Study Design

Total Participants: 917
Study Start date:
October 28, 2010
Estimated Completion Date:
February 28, 2012

Study Description

Androgenetic alopecia is a common, androgen-induced, pattern of progressive loss of scalp hair with an onset at any age after puberty in genetically predisposed people. The influence of androgens on scalp hair growth is mediated by local and systemic conversion of testosterone to dihydrotestosterone , by the enzyme 5 alpha-reductase. 5 alpha-reductase has been shown to exist as 2 isoenzyme forms, Type 1 and Type 2. Type 1 is predominantly located in the skin, both in the hair follicles and sebaceous glands, and is also found in the liver and kidney . Type 2 is the dominant form in male genitalia, including the prostate, although it has also been reported to be present in the inner root sheath of the hair follicle. The presence of both isoenzymes in the hair follicles suggests that both forms are likely to be important in the pathogenesis and treatment of androgenetic alopecia. Inhibition of both Type 1 and Type 2 5 alpha-reductase may be expected to more effectively reduce systemic and local dihydrotestosterone levels than inhibition of either isoenzyme alone.

Finasteride is a selective Type 2 5 alpha-reductase inhibitor that is currently the only approved oral treatment for androgenetic alopecia worldwide. Dutasteride inhibits both Type 1 and Type 2 5alpha-reductase and is approved in more than 80 countries for the treatment of benign prostatic hyperplasia, and in Korea for the treatment of hair loss. Dutasteride is approximately 3 times as potent as finasteride at inhibiting Type 2 5 alpha-reductase and more than 100 times as potent at inhibiting Type 1 5 alpha-reductase.

In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm.

Connect with a study center

  • GSK Investigational Site

    Caba, Buenos Aires C1055AAO
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425BEA
    Argentina

    Site Not Available

  • GSK Investigational Site

    La Boca, Buenos Aires C1155AHD
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Santiago, Región Metro De Santiago 7580206
    Chile

    Site Not Available

  • GSK Investigational Site

    Viña del Mar, Valparaíso 252 0000
    Chile

    Site Not Available

  • GSK Investigational Site

    Viña del Mar, Valparaíso 252 0000
    Chile

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 812-0025
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 532-0003
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 160-0022
    Japan

    Site Not Available

  • GSK Investigational Site

    Naucalpan, Estado De México 11200
    Mexico

    Site Not Available

  • GSK Investigational Site

    Zapopan, Jalisco, Jalisco 45190
    Mexico

    Site Not Available

  • GSK Investigational Site

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mazatlan, Sinaloa, Sinaloa 82126
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico City, 03720
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico city, 06780
    Mexico

    Site Not Available

  • GSK Investigational Site

    Lima 41, Lima Lima 41
    Peru

    Site Not Available

  • GSK Investigational Site

    Lima, Lima 27
    Peru

    Site Not Available

  • GSK Investigational Site

    Lima Cercado, LIMA 01
    Peru

    Site Not Available

  • GSK Investigational Site

    Makati City, 1200
    Philippines

    Site Not Available

  • GSK Investigational Site

    Manila, 1000
    Philippines

    Site Not Available

  • GSK Investigational Site

    Quezon City,
    Philippines

    Site Not Available

  • GSK Investigational Site

    Tanauan City, Batangas, 4232
    Philippines

    Site Not Available

  • GSK Investigational Site

    Moscow,, 107076
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Nizhny Novgorod, 603950
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Ryazan, 390046
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St'Petersburg, 192102
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St-Petersburg, 196084
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Tainan, 70403
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei,
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Bangkoknoi Bangkok, 10700
    Thailand

    Site Not Available

  • GSK Investigational Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • GSK Investigational Site

    Patumwan Bangkok, 10330
    Thailand

    Site Not Available

  • GSK Investigational Site

    Rajthevee Bangkok, 10400
    Thailand

    Site Not Available

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