check_circleStudy Completed
Acne Vulgaris
Bayer Identifier:
91772
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
GA YAZ ACNE in China Phase III
Trial purpose
The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.
Key Participants Requirements
Sex
FemaleAge
14 - 45 YearsTrial summary
Enrollment Goal
179Trial Dates
December 2008 - May 2010Phase
Phase 3Could I Receive a placebo
YesProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | 3rd Affiliated Hosp., Sun Yat-sen Univ. | Guangzhou, 510630, China |
Completed | Changhai Hospital of Second Military Medical University | Shanghai, 200043, China |
Completed | Dermatosis Graduate School of Chinese Academy of Medical Sc | Nanjing, 210042, China |
Completed | Peking Union Medical College Hospital | Beijing, 100032, China |
Completed | Chinese PLA General Hospital | Beijing, 100853, China |
Completed | 2nd Xiangya Hosp., Central South Univ. | Changsha, 410011, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Primary Outcome
- Percent change from Cycle 6 to Baseline in the total lesion count (open and closed comedones, papules, pustules, and nodules) in the FAS (Full Analysis Set)date_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in the total lesion count (open and closed comedones, papules, pustules, and nodules) in the PPS (Per Protocol Set)date_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at screening visitdate_rangeTime Frame:Screening visitenhanced_encryptionNoSafety Issue:
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 1date_rangeTime Frame:Cycle 1 (Day 15±3 days of Treatment Cycle 1)enhanced_encryptionNoSafety Issue:
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 3date_rangeTime Frame:Cycle 3 (Day 15±3 days of Treatment Cycle 3)enhanced_encryptionNoSafety Issue:
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 6date_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6)enhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in inflammatory lesion count (papules, pustules, and nodules), non-inflammatory lesion countdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in lesion count of papulesdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in lesion count of pustulesdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in lesion count of nodulesdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in lesion count of open comedonesdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percent change from Cycle 6 to Baseline in lesion count of closed comedonesdate_rangeTime Frame:Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baselineenhanced_encryptionNoSafety Issue:
- Percentage of participants classified as “improved” according to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Ratingdate_rangeTime Frame:At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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