Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
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|ClinicalTrials.gov Identifier: NCT00651469|
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : December 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) Drug: Placebo||Phase 3|
Expanded Access : Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||534 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety & Efficacy of Oral Contraceptive Prep., Containing Drospirenone 3 mg/Ethinyl Estradiol 20 Mcg for 6 Treatment Cycles in Women With Moderate Acne Vulgaris.|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||July 2004|
|Experimental: Arm 1||
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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).
|Placebo Comparator: Arm 2||
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651469
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|Study Director:||Bayer Study Director||Bayer|