PMID- 19746676 OWN - NLM STAT- MEDLINE DCOM- 20090924 LR - 20220421 IS - 1545-9616 (Print) IS - 1545-9616 (Linking) VI - 8 IP - 9 DP - 2009 Sep TI - A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. PG - 837-44 AB - OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones. RESULTS: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model). CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions. FAU - Maloney, J Michael AU - Maloney JM AD - Cherry Creek Research, Inc, Denver, CO 80209, USA. Drmaloney@cherrycreekdermatology.com FAU - Dietze, Peter Jr AU - Dietze P Jr FAU - Watson, David AU - Watson D FAU - Niknian, Minoo AU - Niknian M FAU - Lee-Rugh, Sooji AU - Lee-Rugh S FAU - Sampson-Landers, Carole AU - Sampson-Landers C FAU - Korner, Paul AU - Korner P LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Drugs Dermatol JT - Journal of drugs in dermatology : JDD JID - 101160020 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/adverse effects/*therapeutic use MH - Contraceptives, Oral, Combined/adverse effects/*therapeutic use MH - Double-Blind Method MH - Ethinyl Estradiol/adverse effects/*therapeutic use MH - Female MH - Humans MH - Middle Aged MH - Treatment Outcome MH - Young Adult EDAT- 2009/09/15 06:00 MHDA- 2009/09/25 06:00 CRDT- 2009/09/15 06:00 PHST- 2009/09/15 06:00 [entrez] PHST- 2009/09/15 06:00 [pubmed] PHST- 2009/09/25 06:00 [medline] PST - ppublish SO - J Drugs Dermatol. 2009 Sep;8(9):837-44.