A new
oral contraceptive has been developed that contains a unique
progestogen,
drospirenone (DRSP), and that has both antiandrogenic and antimineralocorticoid activity. Our objective was to compare the effect of 30 microg
ethinyl estradiol (EE)/3 mg DRSP (EE/DRSP;
Yasmin, Schering AG, Berlin, Germany) with that of 35 microg EE/2 mg
cyproterone acetate (EE/CPA; Diane-35, Schering AG, Berlin, Germany) on mild-to-moderate cases of
acne.
Diane-35 is used worldwide (it is not on the market in the United States and Japan) as a
hormone treatment for
acne, with additional
contraceptive benefits. This multicenter, double-blind, randomized study was completed over 9 treatment cycles. A total of 128 women with mild-to-moderate facial
acne, with or without
seborrhea and/or
hirsutism, were randomized. Treatment with either EE/DRSP or EE/CPA was assigned in a 2:1 ratio.
Acne lesions, sebum production, and hair growth on the upper lip, chin, and chest were assessed, as well as levels of total and free
testosterone,
androstenedione,
dehydroepiandrosterone sulfate (DHEAS),
sex hormone-binding globulin (SHBG), and
luteinizing hormone (LH). At study completion, dermatologists, gynecologists, and subjects gave their overall assessment of the effect of treatment on
acne. After 9 treatment cycles, the median total
acne lesion count was reduced markedly by 62.5% in the EE/DRSP group and 58.8% in the EE/CPA group. A comparison of the 2 groups revealed that EE/DRSP was at least as effective as EE/CPA. Both preparations also reduced sebum production and hair growth on the upper lip and chin. A 3-fold increase in the levels of SHBG was observed in both treatment groups, and levels of
androgens and LH decreased. Treatment differences were not seen. Subjective evaluation of the effect of treatment on facial
acne by dermatologists, gynecologists, and the subjects themselves indicated an excellent or good improvement for most subjects in both groups. EE/DRSP has been shown to be as effective for treating mild-to-moderate
acne as a preparation containing EE/CPA. This new preparation may provide useful
hormone therapy for women with
androgen-dependent disorders who also require
contraception.