Bayer 2011.
Methods | Multicenter trial conducted in China from 2008 to 2010 Double‐blind (subject and investigator) No information on how the randomization schedule was generated. |
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Participants | 179 women, 14 to 45 years old. Inclusion criteria: >1 year post‐menarche with moderate acne vulgaris with no contraindication to COCs; healthy except for moderate acne; smokers up to age 30 (inclusive). Exclusion criteria: pregnancy, lactation (< 3 menstrual cycles since delivery, abortion, or lactation); obesity (Body Mass Index > 30 kg/m2); hypersensitivity to ingredient of study drug; any disease or condition that may worsen under hormonal treatment |
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Interventions | Group 1: Drospirenone (DRSP) 3 mg plus EE 20 µg Group 2: Placebo Duration: 6 cycles |
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Outcomes | Primary: percent change in total lesion count in full analysis and per‐protocol analysis. Secondary: percentage of participants classified as "0" (clear) or "1" (almost clear) on 6‐point ISGA (Investigator Static Global Assessment); percent change in inflammatory and non‐inflammatory lesion counts; percent change in lesion counts of papules, pustules, nodules, open comedones, and closed comedones; percentage of participants classified as 'improved' according to investigator's and participant's overall ratings. Improvement in lesion count is indicated by larger percent change: ((count at baseline ‐ count at cycle 6)/ count at baseline)*100 |
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Notes | Results were posted on ClinicalTrials.gov Study was sponsored by Bayer Schering Pharma Excluded after randomization 6 women who did not take study drug (2 DRSP and 4 placebo) Lost to follow up: DRSP 4/89 (4.5%); placebo 6/90 (6.7%). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | No information |