USE OF AVODART IN ANDROGENETIC ALOPECIA OR MALE PATTERN BALDNESS (HAIRLOSS)

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).

Table 1: Hair count: change from baseline using 0.79 square inch target area

(Intent to Treat Population)*(7)

Avodart

Time/Parameter

0.05mg/day

0.1mg/day

0.5mg/day

2.5mg/day

Finasteride

5mg/day

Placebo

Week 12

Mean *

Mean Difference **

p-value

5.0

27.9

0.065

54.3

77.2

<0.0001

71.9

94.8

<0.001

100.4

123.3

<0.001

52.1

75.0

<0.001

-22.9

Week 24

Mean*

Mean Difference**

p-value

24.8

54.4

<0.001

72.3

101.9

<0.001

95.5

125.1

<0.001

109.8

139.5

<0.001

73.2

102.8

<0.001

-29.6

Week 36

Mean*

Mean Difference**

p-value

-17.1

20.2

0.29

16.8

54.1

0.004

84.3

121.6

<0.001

119.8

157.1

<0.001

13.2

50.5

0.005

-37.3

which are reported as at last visit (ALV) values; * Adjusted for baseline values; ** difference between active treatment and placebo.]

As noted in Table 1, dose-related increases in hair count were seen at 12 and 24 weeks across the Avodart treatment groups. Compared to placebo, these changes were significantly different in all Avodart treatment groups ( P <0.001) except for in the 0.05 group at week 12 ( P<0. 065). Hair count change from baselilne in the finasteride group was also significantly greater than the placebo group at both 12 and 24 weeks ( P< 0.001)(7).

At week 36 (12 weeks after cessation of daily medication), improvement in hair count was maintined at asimilar level to that observed at week 24 in those patients receiving Avodart 0.5mg (35.5 at week 24 and 84.3 at week 36) and 2.5mg (109.9-8 at week 24 and 119.8 at week 36) daily. In contrast, improvement in hair count was not mainteained in those patients receiving finasteride 5mg at week 36 compared to week 24 (73.2 at week 24 and 13.2 at week 36), Advodart 0.05mg (24.8 at week 24 and -17.1 at week 36), or Avodart 0.1mg (72.3 at week 24 and 16.8 at week 36)(7).

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