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Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial.
Obstet Gynecol. 2008 Oct; 112(4):773-81.OG

Abstract

OBJECTIVE

To assess the efficacy of the combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol (3-mg drospirenone/20-microgram ethinyl estradiol) administered as 24 consecutive days of active treatment after a 4-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris.

METHODS

Healthy females aged 14-45 years with moderate acne were randomized in this double-blind study to 3-mg drospirenone/20-microgram ethinyl estradiol (n=270) or placebo (n=268) for six cycles of 28 days. The primary outcome measures of acne lesion counts and Investigator Static Global Assessment scale ratings were assessed at baseline and during cycles 1, 3, and 6.

RESULTS

The percentage reduction from baseline to endpoint for total lesions is 46.3% for 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 combination oral contraceptive group and 30.6% for placebo group (P<.001). The likelihood of participants in the 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen group having "clear" or "almost clear" skin as rated by the investigators at endpoint was about threefold (odds ratio 3.13, 95% confidence interval 1.69-5.81; P=.001) greater than in the placebo group. The 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen was well tolerated.

CONCLUSION

The low-dose combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol administered in a 24/4 regimen significantly reduced acne lesion counts more effectively than placebo and demonstrated greater improvement in the Investigator Static Global Assessment rating of acne. The safety profile was consistent with low-dose combined oral contraceptive use.

Authors+Show Affiliations

Cherry Creek Research, Inc., 3773 Cherry Creek North Drive, Suite 970, Denver, CO 80209, USA. MaloneyMichaelMD@qwestoffice.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18827119

Citation

Maloney, J Michael, et al. "Treatment of Acne Using a 3-milligram Drospirenone/20-microgram Ethinyl Estradiol Oral Contraceptive Administered in a 24/4 Regimen: a Randomized Controlled Trial." Obstetrics and Gynecology, vol. 112, no. 4, 2008, pp. 773-81.
Maloney JM, Dietze P, Watson D, et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 2008;112(4):773-81.
Maloney, J. M., Dietze, P., Watson, D., Niknian, M., Lee-Rugh, S., Sampson-Landers, C., & Korner, P. (2008). Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstetrics and Gynecology, 112(4), 773-81. https://doi.org/10.1097/AOG.0b013e318187e1c5
Maloney JM, et al. Treatment of Acne Using a 3-milligram Drospirenone/20-microgram Ethinyl Estradiol Oral Contraceptive Administered in a 24/4 Regimen: a Randomized Controlled Trial. Obstet Gynecol. 2008;112(4):773-81. PubMed PMID: 18827119.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. AU - Maloney,J Michael, AU - Dietze,Peter,Jr AU - Watson,David, AU - Niknian,Minoo, AU - Lee-Rugh,Sooji, AU - Sampson-Landers,Carole, AU - Korner,Paul, PY - 2008/10/2/pubmed PY - 2008/11/7/medline PY - 2008/10/2/entrez SP - 773 EP - 81 JF - Obstetrics and gynecology JO - Obstet Gynecol VL - 112 IS - 4 N2 - OBJECTIVE: To assess the efficacy of the combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol (3-mg drospirenone/20-microgram ethinyl estradiol) administered as 24 consecutive days of active treatment after a 4-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females aged 14-45 years with moderate acne were randomized in this double-blind study to 3-mg drospirenone/20-microgram ethinyl estradiol (n=270) or placebo (n=268) for six cycles of 28 days. The primary outcome measures of acne lesion counts and Investigator Static Global Assessment scale ratings were assessed at baseline and during cycles 1, 3, and 6. RESULTS: The percentage reduction from baseline to endpoint for total lesions is 46.3% for 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 combination oral contraceptive group and 30.6% for placebo group (P<.001). The likelihood of participants in the 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen group having "clear" or "almost clear" skin as rated by the investigators at endpoint was about threefold (odds ratio 3.13, 95% confidence interval 1.69-5.81; P=.001) greater than in the placebo group. The 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen was well tolerated. CONCLUSION: The low-dose combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol administered in a 24/4 regimen significantly reduced acne lesion counts more effectively than placebo and demonstrated greater improvement in the Investigator Static Global Assessment rating of acne. The safety profile was consistent with low-dose combined oral contraceptive use. SN - 0029-7844 UR - https://www.unboundmedicine.com/medline/citation/18827119/Treatment_of_acne_using_a_3_milligram_drospirenone/20_microgram_ethinyl_estradiol_oral_contraceptive_administered_in_a_24/4_regimen:_a_randomized_controlled_trial_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=18827119.ui DB - PRIME DP - Unbound Medicine ER -