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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.
Contraception. 2008 Apr; 77(4):249-56.C

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+Show Affiliations

Medical Center for Clinical Research, San Diego, CA 92108, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18342647

Citation

Koltun, William, et al. "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." Contraception, vol. 77, no. 4, 2008, pp. 249-56.
Koltun W, Lucky AW, Thiboutot D, et al. 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. Contraception. 2008;77(4):249-56.
Koltun, W., Lucky, A. W., Thiboutot, D., Niknian, M., Sampson-Landers, C., Korner, P., & Marr, J. (2008). 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. Contraception, 77(4), 249-56. https://doi.org/10.1016/j.contraception.2007.11.003
Koltun W, et al. 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. Contraception. 2008;77(4):249-56. PubMed PMID: 18342647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Koltun,William, AU - Lucky,Anne W, AU - Thiboutot,Diane, AU - Niknian,Minoo, AU - Sampson-Landers,Carole, AU - Korner,Paul, AU - Marr,Joachim, Y1 - 2008/03/04/ PY - 2007/05/28/received PY - 2007/11/11/revised PY - 2007/11/20/accepted PY - 2008/3/18/pubmed PY - 2008/6/25/medline PY - 2008/3/18/entrez SP - 249 EP - 56 JF - Contraception JO - Contraception VL - 77 IS - 4 N2 - 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. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/18342647/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(07)00500-8 DB - PRIME DP - Unbound Medicine ER -