Trial Condition(s):
Acne vulgaris
GA YAZ ACNE in China Phase III
Bayer Identifier:
91772
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Women of age 14-45 years - >1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives - Otherwise healthy, except for the presence of moderate acne - Smokers up to a maximum age of 30 (inclusive) at inclusion
Exclusion Criteria
- Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment) - Obesity (Body Mass Index > 30 kg/m2) - Hypersensitivity to any ingredient of the study drug - Any disease or condition that may worsen under hormonal treatment
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations 3rd Affiliated Hosp., Sun Yat-sen Univ. Guangzhou, China, 510630 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhai Hospital of Second Military Medical University Shanghai, China, 200043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatosis Graduate School of Chinese Academy of Medical Sc Nanjing, China, 210042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Union Medical College Hospital Beijing, China, 100032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chinese PLA General Hospital Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd Xiangya Hosp., Central South Univ. Changsha, China, 410011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of an oral contraceptive preparation YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) for 6 treatment cycles in women with moderate acne
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
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)Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- 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)Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Secondary Outcome
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at screening visitTimeframe: Screening visit
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 1Timeframe: Cycle 1 (Day 15±3 days of Treatment Cycle 1)
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 3Timeframe: Cycle 3 (Day 15±3 days of Treatment Cycle 3)
- Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 6Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6)
- Percent change from Cycle 6 to Baseline in inflammatory lesion count (papules, pustules, and nodules), non-inflammatory lesion countTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percent change from Cycle 6 to Baseline in lesion count of papulesTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percent change from Cycle 6 to Baseline in lesion count of pustulesTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percent change from Cycle 6 to Baseline in lesion count of nodulesTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percent change from Cycle 6 to Baseline in lesion count of open comedonesTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percent change from Cycle 6 to Baseline in lesion count of closed comedonesTimeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
- Percentage of participants classified as “improved” according to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment RatingTimeframe: At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)
Additional Information
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