Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

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Brief Title

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Official Title

A Study of the Efficacy and Safety of Multiple Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects With Androgenetic Alopecia

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)

Secondary Outcome

 Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT

Condition

Androgenetic Alopecia

Intervention

1mg Finasteride active

Study Arms / Comparison Groups

 1mg Finasteride
Description:  1mg finasteride active plus dutasteride placebo, by mouth once daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

917

Start Date

October 28, 2010

Completion Date

February 28, 2012

Primary Completion Date

February 1, 2012

Eligibility Criteria

        Inclusion Criteria:

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

        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
      

Gender

Male

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT01231607

Organization ID

114263


Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline


Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline


Verification Date

June 2018