Efficacy of a low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for the treatment of moderate acne: A randomized, placebo-controlled trial.
BACKGROUND
Acne is a multifactorial disease in which androgens appear to play an important role. A low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel (EE/LNG) has been shown to improve biochemical markers of androgenicity. Lowering bioavailable androgens may improve acne.


OBJECTIVE
The aim of this study was to evaluate the efficacy and safety of a low-dose oral contraceptive containing 20 microg of EE and 100 microg of LNG for the treatment of moderate acne.


METHODS
In a randomized, double-blind, placebo-controlled clinical trial, healthy female subjects (n = 371; >/=14 years old) with regular menstrual cycles and moderate facial acne were randomly assigned to receive EE/LNG or placebo for 6 cycles of 28 days. Acne lesion counts and clinician global assessment were performed at the end of each cycle. Patient self-assessments were collected and biochemical markers of androgenicity were also measured.


RESULTS
At the end of the study, the number of inflammatory and total lesions was significantly lower with EE/LNG compared with placebo (P <.05). Patients in the EE/LNG group also had significantly better scores for clinician global and patient self-assessments than those in the placebo group (P <.05). Biochemical markers of androgenicity improved during EE/LNG treatment compared with placebo and baseline values.


CONCLUSIONS
A low-dose oral contraceptive containing EE/LNG is effective and safe for the treatment of moderate acne.
Leyden
James
J
Department of Dermatology, University of Pennsylvania Hospital, Philadelphia, USA.
Shalita
Alan
A
Hordinsky
Maria
M
Swinyer
Leonard
L
Stanczyk
Frank Z
FZ
Weber
Margaret E
ME
D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage*; D008875:Middle Aged; D012449:Safety; D016896:Treatment Outcome
D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D004997:Ethinyl Estradiol; D016912:Levonorgestrel