Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment.

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.

RCT Entities:   Population Interventions Outcomes