PMID- 18342647 OWN - NLM STAT- MEDLINE DCOM- 20080624 LR - 20131121 IS - 0010-7824 (Print) IS - 0010-7824 (Linking) VI - 77 IP - 4 DP - 2008 Apr TI - Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial. PG - 249-56 LID - 10.1016/j.contraception.2007.11.003 [doi] AB - BACKGROUND: A randomized, double-blind, parallel-group study to investigate the efficacy and safety of the 3 mg drospirenone (drsp)/20 mcg ethinylestradiol (EE) combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle) for the treatment of moderate acne vulgaris. STUDY DESIGN: Healthy females (aged 14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 mcg (n=266) or placebo (n=268) for six cycles of 28 days. RESULTS: Women who received the 3 mg drsp/20 mcg EE 24/4 COC had greater reductions from baseline in inflammatory, noninflammatory and total lesion counts. The odds of women in the 3 mg drsp/20 mcg EE 24/4 regimen COC group having 'clear' or 'almost clear' skin as rated by the investigators at end point was about fourfold greater than that in the placebo group (odds ratio 4.31; 95% CI: 2.11-9.60; p=.001). The 3 mg drsp/20 mcg EE 24/4 regimen COC was well tolerated and had a safety profile consistent with low-dose COC use. CONCLUSION: The 3 mg drsp/20 mcg EE 24/4 regimen COC was significantly more effective than placebo in treating moderate acne vulgaris. FAU - Koltun, William AU - Koltun W AD - Medical Center for Clinical Research, San Diego, CA 92108, USA. FAU - Lucky, Anne W AU - Lucky AW FAU - Thiboutot, Diane AU - Thiboutot D FAU - Niknian, Minoo AU - Niknian M FAU - Sampson-Landers, Carole AU - Sampson-Landers C FAU - Korner, Paul AU - Korner P FAU - Marr, Joachim AU - Marr J LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20080304 PL - United States TA - Contraception JT - Contraception JID - 0234361 RN - 0 (Androstenes) RN - 0 (Contraceptives, Oral, Combined) RN - 423D2T571U (Ethinyl Estradiol) RN - N295J34A25 (drospirenone) SB - IM MH - Acne Vulgaris/*drug therapy MH - Adolescent MH - Adult MH - Androstenes/*administration & dosage/adverse effects MH - Contraceptives, Oral, Combined/*administration & dosage/adverse effects MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Ethinyl Estradiol/*administration & dosage/adverse effects MH - Humans MH - Middle Aged MH - Treatment Outcome EDAT- 2008/03/18 09:00 MHDA- 2008/06/25 09:00 CRDT- 2008/03/18 09:00 PHST- 2007/05/28 00:00 [received] PHST- 2007/11/11 00:00 [revised] PHST- 2007/11/20 00:00 [accepted] PHST- 2008/03/18 09:00 [pubmed] PHST- 2008/06/25 09:00 [medline] PHST- 2008/03/18 09:00 [entrez] AID - S0010-7824(07)00500-8 [pii] AID - 10.1016/j.contraception.2007.11.003 [doi] PST - ppublish SO - Contraception. 2008 Apr;77(4):249-56. doi: 10.1016/j.contraception.2007.11.003. Epub 2008 Mar 4.