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.
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).


CONCLUSIONS
The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions.
Maloney
J Michael
JM
Cherry Creek Research, Inc, Denver, CO 80209, USA. Drmaloney@cherrycreekdermatology.com
Dietze
Peter
P
Watson
David
D
Niknian
Minoo
M
Lee-Rugh
Sooji
S
Sampson-Landers
Carole
C
Korner
Paul
P
D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000009:adverse effects / Q000627:therapeutic use*; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; C035144:drospirenone