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Lack of efficacy of finasteride in postmenopausal women with androgenetic alopecia,☆☆,

A preliminary report of the findings from this study was presented at the Hair Workshop, Brussels, Belgium, May 1998.
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Abstract

Background: Finasteride, an inhibitor of type 2 5α-reductase, decreases serum and scalp dihydrotestosterone (DHT) by inhibiting conversion of testosterone to DHT and has been shown to be effective in men with androgenetic alopecia (AGA). The effects of finasteride in women with AGA have not been evaluated. Objective: The purpose of this study was to evaluate the efficacy of finasteride in postmenopausal women with AGA. Methods: In this 1-year, double-blind, placebo-controlled, randomized, multicenter trial, 137 postmenopausal women (41-60 years of age) with AGA received finasteride 1 mg/day or placebo. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, assessment of global photographs by a blinded expert panel, and histologic analysis of scalp biopsy specimens. Results: After 1 year of therapy, there was no significant difference in the change in hair count between the finasteride and placebo groups. Both treatment groups had significant decreases in hair count in the frontal/parietal (anterior/mid) scalp during the 1-year study period. Similarly, patient, investigator, and photographic assessments as well as scalp biopsy analysis did not demonstrate any improvement in slowing hair thinning, increasing hair growth, or improving the appearance of the hair in finasteride-treated subjects compared with the placebo group. Finasteride was generally well tolerated. Conclusion: In postmenopausal women with AGA, finasteride 1 mg/day taken for 12 months did not not increase hair growth or slow the progression of hair thinning. (J Am Acad Dermatol 2000;43:768-76.)

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Patient population

Women were eligible for the study if they were 59 years of age or younger at screening, in good physical and mental health, postmenopausal (and amenorrheic for at least 1 year, but no more than 10 years), and had a serum follicle-stimulating hormone (FSH) level of 40 mIU/mL or more. They had to have mild to moderate frontal hair thinning assessed as grade 1 or 2 on the Ludwig classification3 and 3, 4, or 5 on the Savin Female Density Scale.4, 26

Study design

This was a 1-year, double-blind,

Baseline characteristics

One hundred thirty-seven women with mild to moderate hair thinning in the frontal/mid scalp region were enrolled in the study. The two treatment groups were similar in terms of all baseline characteristics (Table I).

. Baseline characteristics of women randomized to study treatment

Empty CellFinasteride 1 mg (n = 67)Placebo (n = 70)
Mean age ± SD (y)53 ± 453 ± 5
(range 42-60 y)(range 41-60 y)
Mean time since last menses ± SD (y)8 ± 67 ± 5
Mean reported age at onset of hair loss ± SD (y)43 ± 1144 ± 9
(range 14-56

Discussion

This 12-month study demonstrated that finasteride 1 mg did not improve scalp hair growth in postmenopausal women with AGA. Analysis of hair count data after 1 year of therapy revealed that patients in both the finasteride and placebo groups had modest, but statistically significant, decreases in hair counts from baseline. These decreases in hair count for the two treatment groups were not significantly different. Analysis of the other efficacy end points also failed to demonstrate any effect of

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  • Cited by (0)

    Supported by Merck Research Laboratories.

    ☆☆

    Reprint requests: Joanne Waldstreicher, MD, Merck Research Laboratories, RY33-508, 126 East Lincoln Ave, Rahway, NJ 07065-0900.

    J Am Acad Dermatol 2000;43:768-76

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