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Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial.
Contraception. 2009 Jul; 80(1):25-33.C

Abstract

BACKGROUND

The study was conducted to assess the effects of the monophasic combined oral contraceptive containing ethinyl estradiol (EE) 0.03 mg and chlormadinone acetate (CMA) 2 mg (EE/CMA) on papulopustular acne of the face, décolleté (low neck) and back; on moderate comedonal acne of the face; and on seborrhea, alopecia and hirsutism.

STUDY DESIGN

Three hundred seventy-seven women were randomized (2:1) to receive EE/CMA (n=251) or placebo (n=126) for six medication cycles. Due to the placebo-controlled, double-blind design of the trial, condoms were supplied for contraception. The primary efficacy end point was defined as a reduction of at least 50% in the number of papules and/or pustules of the face from admission to Medication Cycle 6.

RESULTS

In total, 64.1% (161/251) of subjects treated with EE/CMA responded compared with 43.7% (55/126) of those taking placebo (p=.0001). The median reduction in papules/pustules on the face at Cycle 6 compared with admission was 63.6% (EE/CMA) compared with 45.3% (placebo group). For comedonal lesions of the face, the reduction in lesion numbers was 54.8% (EE/CMA) compared with 32.4% (placebo). Moderate papulopustular acne of the décolleté decreased by 92.9% (EE/CMA) vs. 50% (placebo group) and of the back by 86.0% and 58.3%, respectively. For these skin conditions, the p values for the relative difference between groups vs. baseline were <.05 at Cycles 3 and 6, in favor of EE/CMA. As part of a self-assessment rating, at least 70.5% (EE/CMA) vs. 41.3% (placebo) reported an at least satisfactory improvement of their moderate acne. Even 39.8% of women taking EE/CMA reported an "excellent improvement" or "complete resolution" of moderate acne compared with 12.7% taking placebo.

CONCLUSION

In addition to its contraceptive efficacy described elsewhere, EE/CMA is an effective treatment for moderate papulopustular acne and other androgen-related skin disorders.

Authors+Show Affiliations

Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians-Universität, München, Germany. gerd.plewig@med.uni-muenchen.deNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19501212

Citation

Plewig, Gerd, et al. "Efficacy of an Oral Contraceptive Containing EE 0.03 Mg and CMA 2 Mg (Belara) in Moderate Acne Resolution: a Randomized, Double-blind, Placebo-controlled Phase III Trial." Contraception, vol. 80, no. 1, 2009, pp. 25-33.
Plewig G, Cunliffe WJ, Binder N, et al. Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Contraception. 2009;80(1):25-33.
Plewig, G., Cunliffe, W. J., Binder, N., & Höschen, K. (2009). Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Contraception, 80(1), 25-33. https://doi.org/10.1016/j.contraception.2009.02.016
Plewig G, et al. Efficacy of an Oral Contraceptive Containing EE 0.03 Mg and CMA 2 Mg (Belara) in Moderate Acne Resolution: a Randomized, Double-blind, Placebo-controlled Phase III Trial. Contraception. 2009;80(1):25-33. PubMed PMID: 19501212.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. AU - Plewig,Gerd, AU - Cunliffe,William J, AU - Binder,Natascha, AU - Höschen,Kornelia, Y1 - 2009/05/09/ PY - 2008/05/06/received PY - 2009/02/15/revised PY - 2009/02/15/accepted PY - 2009/6/9/entrez PY - 2009/6/9/pubmed PY - 2009/9/16/medline SP - 25 EP - 33 JF - Contraception JO - Contraception VL - 80 IS - 1 N2 - BACKGROUND: The study was conducted to assess the effects of the monophasic combined oral contraceptive containing ethinyl estradiol (EE) 0.03 mg and chlormadinone acetate (CMA) 2 mg (EE/CMA) on papulopustular acne of the face, décolleté (low neck) and back; on moderate comedonal acne of the face; and on seborrhea, alopecia and hirsutism. STUDY DESIGN: Three hundred seventy-seven women were randomized (2:1) to receive EE/CMA (n=251) or placebo (n=126) for six medication cycles. Due to the placebo-controlled, double-blind design of the trial, condoms were supplied for contraception. The primary efficacy end point was defined as a reduction of at least 50% in the number of papules and/or pustules of the face from admission to Medication Cycle 6. RESULTS: In total, 64.1% (161/251) of subjects treated with EE/CMA responded compared with 43.7% (55/126) of those taking placebo (p=.0001). The median reduction in papules/pustules on the face at Cycle 6 compared with admission was 63.6% (EE/CMA) compared with 45.3% (placebo group). For comedonal lesions of the face, the reduction in lesion numbers was 54.8% (EE/CMA) compared with 32.4% (placebo). Moderate papulopustular acne of the décolleté decreased by 92.9% (EE/CMA) vs. 50% (placebo group) and of the back by 86.0% and 58.3%, respectively. For these skin conditions, the p values for the relative difference between groups vs. baseline were <.05 at Cycles 3 and 6, in favor of EE/CMA. As part of a self-assessment rating, at least 70.5% (EE/CMA) vs. 41.3% (placebo) reported an at least satisfactory improvement of their moderate acne. Even 39.8% of women taking EE/CMA reported an "excellent improvement" or "complete resolution" of moderate acne compared with 12.7% taking placebo. CONCLUSION: In addition to its contraceptive efficacy described elsewhere, EE/CMA is an effective treatment for moderate papulopustular acne and other androgen-related skin disorders. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/19501212/Efficacy_of_an_oral_contraceptive_containing_EE_0_03_mg_and_CMA_2_mg__Belara__in_moderate_acne_resolution:_a_randomized_double_blind_placebo_controlled_Phase_III_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(09)00082-1 DB - PRIME DP - Unbound Medicine ER -