A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Tapinarof Cream, 1% (Sun Pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the Treatment of Plaque Psoriasis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 575
- 试验地点
- 1
- 主要终点
- Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
研究概览
简要总结
To demonstrate therapeutic equivalence and safety of Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of plaque psoriasis.
详细描述
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of 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
- Single (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
- 是
入选标准
- •Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
- •Subjects must have provided IRB approved written informed consent.
- •Subjects must have a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3% to 20% body surface area (BSA), not including the face, scalp, groin, palms, fingernails, toenails, and soles in the BSA calculation.
- •Subjects must have plaque psoriasis with a Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
排除标准
- •Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation.
- •Subjects with a known hypersensitivity to tapinarof or to any ingredients in the study drugs.
- •Subjects with a current diagnosis of drug-induced psoriasis or unstable forms of psoriasis, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- •Subjects with spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis as determined by the investigator.
研究组 & 干预措施
Tapinarof Cream, 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Tapinarof Cream, 1% (Drug)
Vtama® (Tapinarof) Cream, 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Vtama® (Tapinarof) Cream, 1% (Drug)
Placebo Control
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Placebo Control (Drug)
结局指标
主要结局
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
时间窗: Baseline to Week 12
The proportion of subjects in each treatment group with treatment success with a minimum 2-grade improvement.
次要结局
未报告次要终点