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March 2007

The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia


The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.

Study Type: Interventional

Study Design: 

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 

An Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Dutasteride 0.5mg Once Daily for 6 Months in the Treatment of Male Subjects With Androgenetic Alopecia (Norwood-Hamilton Classification Type IIIv, IV and V)

Further study details as provided by GlaxoSmithKline:
Primary Outcomes: 

Hair growth assessed by macrophotographic technique (hair count) in the vertex at 6 months.

Secondary Outcomes: 

Subject assessment of change in hair growth and loss. Panel and investigator photographic assessment of change in hair growth Hormone measurements of LH at screening and DHT, testosterone, TSH, and T4. Assessment of sexual function

Expected Total Enrollment:  150

Study start: December 2006
 
Eligibility

Ages Eligible for Study:  18 Years   -   49 Years,  Genders Eligible for Study:  Male Criteria Inclusion criteria: Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (N.B. types IVa and Va are excluded)

Exclusion criteria:

Global scalp hair thinning, including occipital areas

  • Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.

  • Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair.

  • Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening.

  • Previous use of dutasteride.

  • Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.

  • Use of the following during the 6 months prior to screening:

      Minoxidil (oral or topical)

    • Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.

    • Topical estrogen, progesterone

    • Tamoxifen

    • Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)

    • Anabolic steroids

    • Lithium and phenothiazines