Androgenetic Alopecia Clinical Trial
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
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.
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.
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