PMID- 21288628 OWN - NLM STAT- MEDLINE DCOM- 20110725 LR - 20131121 IS - 1872-7654 (Electronic) IS - 0301-2115 (Linking) VI - 155 IP - 2 DP - 2011 Apr TI - Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 mug plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis. PG - 171-5 LID - 10.1016/j.ejogrb.2010.12.027 [doi] AB - OBJECTIVE: To investigate the effects of an ethinylestradiol (EE) 20 mug/drospirenone (drsp) 3mg 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 mug/drsp 3mg 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 mug/drsp 3mg 24/4 COC group compared with the placebo group (P<0.0001). The odds of women in the EE 20 mug/drsp 3mg 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 mug/drsp 3mg (24/4) more effectively reduced acne lesions than placebo and demonstrated greater improvement in the investigator global assessment of acne. CI - Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved. FAU - Koltun, William AU - Koltun W AD - Medical Center for Clinical Research, San Diego, CA, USA. FAU - Maloney, J Michael AU - Maloney JM FAU - Marr, Joachim AU - Marr J FAU - Kunz, Michael AU - Kunz M LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110202 PL - Ireland TA - Eur J Obstet Gynecol Reprod Biol JT - European journal of obstetrics, gynecology, and reproductive biology JID - 0375672 RN - 0 (Androstenes) RN - 0 (Contraceptives, Oral, Combined) RN - 0 (Estrogens) RN - 0 (Progestins) RN - 423D2T571U (Ethinyl Estradiol) RN - N295J34A25 (drospirenone) SB - IM MH - Acne Vulgaris/*drug therapy MH - Adolescent MH - Adult MH - Androstenes/administration & dosage/*therapeutic use MH - Contraceptives, Oral, Combined/administration & dosage/*therapeutic use MH - Double-Blind Method MH - Estrogens/administration & dosage/therapeutic use MH - Ethinyl Estradiol/administration & dosage/*therapeutic use MH - Female MH - Humans MH - Progestins/administration & dosage/therapeutic use MH - Severity of Illness Index MH - Young Adult EDAT- 2011/02/04 06:00 MHDA- 2011/07/26 06:00 CRDT- 2011/02/04 06:00 PHST- 2010/03/19 00:00 [received] PHST- 2010/12/07 00:00 [revised] PHST- 2010/12/27 00:00 [accepted] PHST- 2011/02/04 06:00 [entrez] PHST- 2011/02/04 06:00 [pubmed] PHST- 2011/07/26 06:00 [medline] AID - S0301-2115(11)00008-X [pii] AID - 10.1016/j.ejogrb.2010.12.027 [doi] PST - ppublish SO - Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.