A randomized, controlled trial of a low-dose contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for acne treatment.
OBJECTIVE
To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 microg of levonorgestrel (LNG) and 20 microg of ethinyl estradiol (EE) compared with placebo for the treatment of moderate acne.


METHODS
Multicenter, randomized, double-blind, placebo-controlled clinical trial.


METHODS
Outpatient dermatology clinics.


METHODS
Women (> or =14 years old; n = 350) with normal menstrual cycles and moderate acne were randomized to receive LNG/EE or placebo for six cycles.


METHODS
Twenty microg of EE and 100 microg of LNG.


METHODS
Acne lesion counts and clinician global assessment were performed at baseline and at each cycle. Patient self-assessment was carried out at baseline and at cycles 4 and 6; blood pressure and weight were measured at baseline and at cycles 1, 3, and 6.


RESULTS
Inflammatory, noninflammatory, and total lesion counts at cycle 6 with LNG/EE were significantly lower compared to placebo. Patients in the LNG/EE group also had significantly better clinician global and patient self-assessment scores than those in the placebo group at cycle. Changes in weight from baseline were similar between patients in the LNG/EE and placebo groups at all measured time points.


CONCLUSIONS
This double-blind, placebo-controlled study demonstrates that a low-dose OC containing 20 microg of EE and 100 microg of LNG is an effective and safe treatment for moderate acne.
Thiboutot
D
D
Division of Dermatology, Pennsylvania State University, Hershey, USA.
Archer
D F
DF
Lemay
A
A
Washenik
K
K
Roberts
J
J
Harrison
D D
DD
D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D001794:Blood Pressure; D001835:Body Weight; D003277:Contraceptives, Oral, Combined / Q000627:therapeutic use*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D011795:Surveys and Questionnaires
D003277:Contraceptives, Oral, Combined; D010919:Placebos; D004997:Ethinyl Estradiol; D016912:Levonorgestrel