Enrico Carmina1, Rogerio A Lobo. 1. Department of Obstetrics and Gynecology, University of Palermo, Palermo, Italy.
Abstract
OBJECTIVE: To determine the effectiveness of various antiandrogens for the treatment of premenopausal women with hyperandrogenic alopecia. DESIGN: Randomized, unmasked trial of three treatments in 36 hyperandrogenic women with alopecia and observation, without treatment, in 12 other similar patients. SETTING:Endocrinologic outpatient practice in Italy. PARTICIPANT(S): A total of 48 hyperandrogenic women with alopecia and 30 age- and weight-matched controls for the assessment of androgen levels. INTERVENTION(S): Randomization to cyproterone acetate (50 mg) with ethinyl estradiol (EE) in a reverse sequential regimen; flutamide (250 mg) or finasteride (5 mg) daily; all for 1 year. Twelve similar patients were observed without treatment for 1 year. MAIN OUTCOME MEASURE(S): Ludwig scores for hair thinning as well as patient and investigator assessments of treatment effectiveness. RESULT(S): Flutamide resulted in a reduction of 21% in Ludwig scores (2.3 +/- 0.2 to 1.8 +/- 0.1). The other treatment effects were not statistically significant. Patient and investigator assessments showed a similar trend. CONCLUSION(S): Flutamide at a dose of 250 mg daily induced a modest improvement in alopecia after 1 year, whereas cyproterone acetate and finasteride were not effective. Treatment for more than 1 year may be required for better results.
RCT Entities:
OBJECTIVE: To determine the effectiveness of various antiandrogens for the treatment of premenopausal women with hyperandrogenic alopecia. DESIGN: Randomized, unmasked trial of three treatments in 36 hyperandrogenicwomen with alopecia and observation, without treatment, in 12 other similar patients. SETTING: Endocrinologic outpatient practice in Italy. PARTICIPANT(S): A total of 48 hyperandrogenicwomen with alopecia and 30 age- and weight-matched controls for the assessment of androgen levels. INTERVENTION(S): Randomization to cyproterone acetate (50 mg) with ethinyl estradiol (EE) in a reverse sequential regimen; flutamide (250 mg) or finasteride (5 mg) daily; all for 1 year. Twelve similar patients were observed without treatment for 1 year. MAIN OUTCOME MEASURE(S): Ludwig scores for hair thinning as well as patient and investigator assessments of treatment effectiveness. RESULT(S): Flutamide resulted in a reduction of 21% in Ludwig scores (2.3 +/- 0.2 to 1.8 +/- 0.1). The other treatment effects were not statistically significant. Patient and investigator assessments showed a similar trend. CONCLUSION(S): Flutamide at a dose of 250 mg daily induced a modest improvement in alopecia after 1 year, whereas cyproterone acetate and finasteride were not effective. Treatment for more than 1 year may be required for better results.