A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 10
- 主要终点
- Change in Inflammatory Lesion Counts From Baseline
研究概览
简要总结
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 years of age or older
- •Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
- •Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
- •Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study
排除标准
- •Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
- •Allergy or sensitivity to ingredients in test product
- •Any dermatological conditions of the face that may interfere with study evaluations
- •Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea
研究组 & 干预措施
DER 45 EV Gel, 1%
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
干预措施: DER 45 EV (Drug)
Vehicle
Placebo Gel applied topically once a day for 12 weeks
干预措施: Vehicle (Drug)
DER 45 EV Gel, 5%
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
干预措施: DER 45 EV (Drug)
结局指标
主要结局
Change in Inflammatory Lesion Counts From Baseline
时间窗: Baseline to Week 12 / end of treatment
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Investigator Global Assessment (IGA) Improvement From Baseline
时间窗: Baseline to Week 12 / end of treatment
The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
次要结局
未报告次要终点