Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Drug: 0.1mg dutasteride; Drug: Dutasteride placebo; Drug: 0.5mg dutasteride; Drug: Finasteride placebo; Drug: 1mg Finasteride active; Drug: 0.02mg dutasteride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01231607

114263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 917 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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917 participants in 5 patient groups, including a placebo group

1mg Finasteride

Active Comparator group

Description:

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

Treatment:

Drug: 1mg Finasteride active

Drug: Dutasteride placebo

0.02mg Dutasteride

Active Comparator group

Description:

0.02mg dutasteride active plus finasteride placebo, by mouth once daily

Treatment:

Drug: 0.02mg dutasteride

Drug: Finasteride placebo

0.1mg Dutasteride

Active Comparator group

Description:

0.1mg dutasteride active plus finasteride placebo, by mouth once daily

Treatment:

Drug: Finasteride placebo

Drug: 0.1mg dutasteride

0.5mg Dutasteride

Active Comparator group

Description:

0.5mg dutasteride active plus finasteride placebo, by mouth once daily

Treatment:

Drug: Finasteride placebo

Drug: 0.5mg dutasteride

Placebo

Placebo Comparator group

Description:

1mg finasteride placebo plus dutasteride placebo, by mouth once daily

Treatment:

Drug: Finasteride placebo

Drug: Dutasteride placebo