A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 855
- 试验地点
- 1
- 主要终点
- Treatment Success Assessed by IGA
研究概览
简要总结
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
- •Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
- •Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.
排除标准
- •A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
- •Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
- •Have a history of psoriasis unresponsive to topical treatments
研究组 & 干预措施
Test
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
干预措施: Tazarotene Cream 0.05% (Drug)
Reference
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
干预措施: TAZORAC® (tazarotene) Cream 0.05% (Drug)
Placebo
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Success Assessed by IGA
时间窗: Week 12
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
次要结局
- Disease Severity None or Minimal on IGA(Week 12)
- Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI(Week 12)