Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 μg plus drospirenone 3 mg administered in a 24/4 regimen: a pooled analysis

Abstract Objective To investigate the effects of an ethinylestradiol (EE) 20 μg/drospirenone (drsp) 3 mg combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets/4 inert tablets per cycle) for the treatment of moderate acne vulgaris, based on a pooled analysis of two identically designed US studies. Study design Healthy females ( n = 893) aged 14–45 years with moderate facial acne were randomised to EE 20 μg/drsp 3 mg COC ( n = 451) or placebo ( n = 442) for six cycles. Primary outcome measures were mean percent change in acne lesion counts and the investigators’ assessment of acne from baseline to endpoint. Results There were significantly greater reductions in the mean percent change from baseline to endpoint in inflammatory, non-inflammatory and total lesion counts in the EE 20 μg/drsp 3 mg 24/4 COC group compared with the placebo group ( P < 0.0001). The odds of women in the EE 20 μg/drsp 3 mg 24/4 COC group having ‘clear’ or ‘almost clear’ skin as rated by the investigators at endpoint were around three-fold greater than in the placebo group (odds ratio 3.41; 95% CI: 2.15–5.43; P < 0.0001). Conclusions A low-dose COC containing EE 20 μg/drsp 3 mg (24/4) more effectively reduced acne lesions than placebo and demonstrated greater improvement in the investigator global assessment of acne.