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