Clinical information
A phase 2, multi-center, double blind, placebo-controlled study was conducted in 416 males with AGA, ages 21 to 45 year, to evaluate the dose response relationship of repeated doses of Avodart (0.05mg, 0.1mg,0.5mg, and 2.5mg daily) on hair count compared to placebo for 6 months. Safety and tolerability of the varying doses of Avodart and fiasteridde 5mg daily compared with placebo were also investigated. At the time this study was cnducted, the 1-mg dosage strength of finasteride that is currently approved for the treatment of AGA was not available (7).
Patients were included in this study If they had MPHL defined as type IIIv, IV, or V by the modified Norwood-Hamilton classification and had active hair loss or progression in the size of the balding area withig the past 2 years. Patients were randomized into one of the following xix treatment groups: Avodart 0.05mg (n=71), Avodart 0.1mg (n=72), Avodart 0.5mg (n=71), finasteride 5mg (n=70), or placebo (n=64) (7). Patients received oral doses once daily for 24 weeks. The study also included and additional follow-up visit and evaluation of hair count at 36 weeks (12 weeks after double-blind study medication had been stopped) (7).
Efficacy was assessed by measuring hair counts of the vertex region of the scalp susing macrophotographic techniques at baseline, 12 weeks, 24 weeks, and at the follow-up visit at 36 weeks (12 weeks after study medication discontinuation). Ther primary efficacy parameter was the hair count ina 1-inch diameter circle, with a target area of 0.79 square inches, surrounding a tattoo. Results are presented in Table 1 and reflect last observation carried forward (LOCF) (weeks 12 and 24) or at the last visit (ALV) (week 36) analyses of the intent-to-treat population (7). |
