This double-blind study compared the efficacy and tolerability of a
combined oral contraceptive containing 30 microg
ethinyl estradiol and 3 mg
drospirenone (EE/DRSP;
Yasmin) with a triphasic preparation containing 35 microg EE and 0.180, 0.215, 0.250 mg
norgestimate (EE/NGM; Pramino, also known as
Ortho Tri-Cyclen) in the treatment of
acne vulgaris. The combined presence of antiandrogenic and antimineralocorticoid activities of
drospirenone is unique to this novel
progestin in that these characteristics most closely resemble those of
progesterone. The study was designed to show that EE/DRSP was noninferior or superior to EE/NGM as to the relative decrease from baseline to cycle 6 in percentage of inflammatory and total lesion counts and the investigators' assessment of
acne improvement. Other outcomes included subjects' assessment of
therapeutic effect, sebum production, and
hormone levels. Female subjects were randomized to EE/DRSP (n = 568) or EE/NGM (n = 586) for 6 treatment cycles, consisting of 21 consecutive days of
hormone intake, followed by 7
hormone-free days. The preparation containing EE/DRSP was superior to EE/NGM for reduction in total lesion count (-3.3% in favor of EE/DRSP [95% CI, -6.5 to -0.1; P = .020]) and for investigators' assessment of
therapeutic effect on facial
acne (+3.6% in favor of EE/DRSP [95% CI, 0.8 to 6.3; P = .006]). The 2 preparations were comparable as to their decreases in inflammatory lesion count. Evaluation of the effect of treatment by subjects was consistent with that of the investigators. Furthermore, both preparations increased the level of
sex hormone-binding globulin (SHBG) and decreased the levels of
androgens, changes typically associated with
acne improvement. Both preparations were well tolerated. In conclusion, owing to the unique pharmacologic activities of
drospirenone, the
combined oral contraceptive EE/DRSP provides an effective treatment option in female patients with mild to moderate
acne.