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A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment.
J Drugs Dermatol. 2009 Sep; 8(9):837-44.JD

Abstract

OBJECTIVE

To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris.

METHODS

Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones.

RESULTS

There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model).

CONCLUSION

The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions.

Authors+Show Affiliations

Cherry Creek Research, Inc, Denver, CO 80209, USA. Drmaloney@cherrycreekdermatology.comNo 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

19746676

Citation

Maloney, J Michael, et al. "A Randomized Controlled Trial of a Low-dose Combined Oral Contraceptive Containing 3 Mg Drospirenone Plus 20 Microg Ethinylestradiol in the Treatment of Acne Vulgaris: Lesion Counts, Investigator Ratings and Subject Self-assessment." Journal of Drugs in Dermatology : JDD, vol. 8, no. 9, 2009, pp. 837-44.
Maloney JM, Dietze P, Watson D, et al. A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. J Drugs Dermatol. 2009;8(9):837-44.
Maloney, J. M., Dietze, P., Watson, D., Niknian, M., Lee-Rugh, S., Sampson-Landers, C., & Korner, P. (2009). A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. Journal of Drugs in Dermatology : JDD, 8(9), 837-44.
Maloney JM, et al. A Randomized Controlled Trial of a Low-dose Combined Oral Contraceptive Containing 3 Mg Drospirenone Plus 20 Microg Ethinylestradiol in the Treatment of Acne Vulgaris: Lesion Counts, Investigator Ratings and Subject Self-assessment. J Drugs Dermatol. 2009;8(9):837-44. PubMed PMID: 19746676.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. 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 - 2009/9/15/entrez PY - 2009/9/15/pubmed PY - 2009/9/25/medline SP - 837 EP - 44 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 8 IS - 9 N2 - OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones. RESULTS: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model). CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/19746676/A_randomized_controlled_trial_of_a_low_dose_combined_oral_contraceptive_containing_3_mg_drospirenone_plus_20_microg_ethinylestradiol_in_the_treatment_of_acne_vulgaris:_lesion_counts_investigator_ratings_and_subject_self_assessment_ L2 - https://medlineplus.gov/acne.html DB - PRIME DP - Unbound Medicine ER -