PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.
Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.
At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.
The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.
Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.
"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."
It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.
However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.
Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.
Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.
The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.
Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.
Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.