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.

Abstract

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.

• Authors: William Koltun, Anne W Lucky, Diane Thiboutot, Minoo Niknian, Carole Sampson-Landers, Paul Korner, Joachim Marr
• Journal: Contraception (Contraception) Vol. 77 Issue 4 Pg. 249-56 (Apr 2008) ISSN: 0010-7824 [Print] United States
• PMID: 18342647 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstenes
• Contraceptives, Oral, Combined
• Ethinyl Estradiol
• drospirenone

Topics

• Acne Vulgaris (drug therapy)
• Adolescent
• Adult
• Androstenes (administration & dosage, adverse effects)
• Contraceptives, Oral, Combined (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Ethinyl Estradiol (administration & dosage, adverse effects)
• Humans
• Middle Aged
• Treatment Outcome