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

William Koltun; Anne W. Lucky; Diane Thiboutot; Minoo Niknian; Carole Sampson-Landers; Paul Korner; Joachim Marr

doi:10.1016/j.contraception.2007.11.003

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

William Koltun, Anne W. Lucky, Diane Thiboutot, Minoo Niknian, Carole Sampson-Landers, Paul Korner, Joachim Marr

Research output: Contribution to journal › Article › peer-review

82 Scopus citations

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.

Original language	English (US)
Pages (from-to)	249-256
Number of pages	8
Journal	Contraception
Volume	77
Issue number	4
DOIs	https://doi.org/10.1016/j.contraception.2007.11.003
State	Published - Apr 2008

All Science Journal Classification (ASJC) codes

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/j.contraception.2007.11.003

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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), 249-256. https://doi.org/10.1016/j.contraception.2007.11.003

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title = "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.",

author = "William Koltun and Lucky, {Anne W.} and Diane Thiboutot and Minoo Niknian and Carole Sampson-Landers and Paul Korner and Joachim Marr",

note = "Funding Information: Funding for this study (protocol number 306820) was provided by Bayer Schering Pharma AG, Berlin, Germany. The authors would like to thank Danielle Werakso for editorial assistance.",

year = "2008",

month = apr,

doi = "10.1016/j.contraception.2007.11.003",

language = "English (US)",

volume = "77",

pages = "249--256",

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Koltun, W, Lucky, AW, 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, vol. 77, no. 4, pp. 249-256. https://doi.org/10.1016/j.contraception.2007.11.003

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. / Koltun, William; Lucky, Anne W.; Thiboutot, Diane et al.
In: Contraception, Vol. 77, No. 4, 04.2008, p. 249-256.

Research output: Contribution to journal › Article › peer-review

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T1 - Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris

T2 - 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

N1 - Funding Information: Funding for this study (protocol number 306820) was provided by Bayer Schering Pharma AG, Berlin, Germany. The authors would like to thank Danielle Werakso for editorial assistance.

PY - 2008/4

Y1 - 2008/4

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.

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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

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