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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 179
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EE20/Drospirenone (YAZ, BAY86-5300)
In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
干预措施: EE20/Drospirenone (YAZ, BAY86-5300) (Drug)
Placebo
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
干预措施: Placebo (Drug)
结局指标
主要结局
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)
时间窗: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
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)
时间窗: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
次要结局
- Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit(Screening visit)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1(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 3(Cycle 3 (Day 15±3 days of Treatment Cycle 3))
- Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6(Cycle 6 (Day 15±3 days of Treatment Cycle 6))
- Percent Change From Cycle 6 to Baseline in Lesion Count of Papules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones(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 Rating(At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle))