Kimball 2011.

Trial name or title	A study to examine the safety and efficacy of drospirenone and ethinyl estradiol (YAZ) compared with placebo In the treatment of moderate truncal acne vulgaris
Methods	Randomized, double‐blind trial
Participants	100 females, 18 to 45 years old. Inclusion criteria: achieved spontaneous menarche, clinical diagnosis of truncal acne vulgaris and desire for oral contraceptive for birth control, minimum of 10 but not more than 50 inflammatory lesions on back and chest combined, maximum of 5 nodules. Exclusion criteria: Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks Use of oral antibiotics within 30 days. Use of systemic corticosteroids within 4 weeks. Use of oral contraceptives within 12 weeks. Use of isotretinoin in past six months. Use of phototherapy devices for acne such as ClearLight or Zenozapper within 1 week. Use of tanning booths or lamps within 1 week prior to baseline. BMI >30 History of renal insufficiency History of hepatic dysfunction History of adrenal Insufficiency History of vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders History of hypertension Diabetes mellitus with vascular involvement Migraine headaches with focal neurological symptoms Recent major surgery with prolonged immobilization Known or suspected carcinoma of the breast Carcinoma of the endometrium or other known or suspected estrogen‐dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Liver tumor (benign or malignant) or active liver disease Smoking > ½ pack of cigarettes/week Regular intake of medications that may increase potassium levels such as NSAIDS, potassium sparing diuretics, potassium supplementation, ACE inhibitors, Angiotensin‐II receptor antagonists, heparin and aldosterone antagonists. Hypersensitivity to any component of the study drug Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study. Subjects who are known to be pregnant or planning a pregnancy.
Interventions	Drospirenone and ethinyl estradiol (YAZ) daily versus placebo (daily)
Outcomes	Primary: percent change in truncal lesion counts (24 weeks) Secondary: percentage of subjects rated clear or almost clear on Investigator's Global Assessment (IGA) of truncal acne and all acne at week 24 and change in truncal lesion counts, subject's assessment of acne at week 24/early termination
Starting date	Jul 2008; estimated completion Jul 2012
Contact information	Lynne M Hermosilla, 617‐726‐5066, harvardskinstudies@partners.org
Notes