The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
534
The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Unnamed facility
Birmingham, Alabama, United States
Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
Time frame: From baseline to Cycle 6
Change from baseline in count of papules
Time frame: Visits 3-5
Change from baseline in count of pustules
Time frame: Visits 3-5
Change from baseline in count of nodules
Time frame: Visits 3-5
Change from baseline in count of open comedones
Time frame: Visits 3-5
Change from baseline in count of closed comedones
Time frame: Visits 3-5
Percentage of subjects classified as "improved" according to the Investigator's Overall Improvement Rating
Time frame: Visits 3-5
Percentage of subjects classifying themselves as "improved" on the Subject's Overall Self-Assessment Rating
Time frame: Visits 3-5
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Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Mesa, Arizona, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
Unnamed facility
Boise, Idaho, United States
...and 17 more locations