J&J 2005.

Methods	Randomized controlled trial conducted in Taiwan from Sep 2004 to Sep 2005 No information on randomization method. Double‐blind (did not specify who was blinded)
Participants	48 women, 15 to 49 years. Inclusion Criteria: moderate acne vulgaris (grade II or III), 6 to 100 comedones (non‐inflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), fewer than 5 nodules; agree to condoms or diaphragm, and spermicide or other medically approved effective barrier contraceptive or non‐hormonal IUD; agree to take as treatment for acne only supplied study drug during 3‐month treatment phase. Exclusion Criteria: in investigator's opinion, cannot understand or follow study instructions, pregnant or nursing, clinical depression and suicidal or require immediate treatment for depression, known hypersensitivity to any ingredient, significant adverse experiences from ethinyl estradiol or norgestimate, coexisting medical condition or taking concomitant medication likely to interfere with safe administration of TriCilest or Diane‐35; took systemic retinoids, systemic antimicrobials, and topical acne treatments in past 6 months, 1 month, and 2 weeks, respectively; any contraindication to oral contraceptives: current or past thrombophlebitis or thromboembolic disorder, cerebral vascular or coronary artery disease or known severe hypertension, diabetes with vascular involvement, known or suspected carcinoma of the breast, known or suspected estrogen‐dependent neoplasia; undiagnosed, abnormal genital bleeding; liver tumor, jaundice or severe liver disease, neurovascular lesion of the eye or serious visual disturbances, known allergic reaction or sensitivities to TriCilest or Diane 35; took an investigational medication in past 30 days (or in period of five times its half‐life or the half‐life of its metabolites)
Interventions	Group 1: norgestimate 180‐215‐250 µg plus ethinyl estradiol 35 µg Group 2: cyproterone acetate 2 mg plus EE 35 µg Duration: 3 cycles
Outcomes	Primary: change in total lesion count from baseline to latest available evaluation Secondary: change in inflammatory lesion count, change in individual lesion count, percentage of participants showing improvement on investigator's global assessment, participant's end‐of‐therapy self‐assessment.
Notes	Unpublished report was obtained from a link on ClinicalTrials.gov. For secondary outcomes, no data were provided. Report noted the study groups were not significantly different regarding treatment effect for these counts. Study was sponsored by Johnson & Johnson Taiwan Ltd. Excluded from analysis 3 participants who did not take any study drug (comparison). Loss to follow up: no information
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	No information