Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- clinical success on the Physician's Global Assessment (PASI) of disease severity
研究概览
简要总结
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.
详细描述
Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp 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
- Quadruple (Participant, Care Provider, 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
- •Healthy male or non-pregnant female aged ≥18 years
- •All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
- •Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
- •A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp
排除标准
- •Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
- •Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
- •Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis
研究组 & 干预措施
Test Product
Betamethasone Scalp Suspension 0.064%;0.0005% (Taro Pharmaceuticals Inc.)
干预措施: Betamethasone Scalp Suspension 0.064%;0.0005% (Drug)
Reference Product
Taclonex® (Calcipotriene Hydrate and Betamethasone Dipropionate) Topical suspension 0.005%/0.064% (LEO PHARMA)
干预措施: Taclonex® (Drug)
Placebo
Vehicle of the test product (Taro Pharmaceuticals Inc.)
干预措施: Placebo topical suspension (Drug)
结局指标
主要结局
clinical success on the Physician's Global Assessment (PASI) of disease severity
时间窗: Study Week 4 (Day 28 ± 4 days)
The proportion of subjects in each treatment group with "clinical success" (defined as clear or almost clear, a score of 0 or 1, at the target lesion site) on the PASI. Each psoriatic sign of scaling, erythema and plaque elevation should have a score of 0 or 1 for the subject to be considered a clinical success. The target lesion is to be identified at Baseline as the most severe lesion.
treatment success on the Physician's Global Assessment (PGA) of disease severity
时间窗: Study Week 4 (Day 28 ± 4 days)
The proportion of subjects in each treatment group with "treatment success" (defined as none or minimal, a score of 0 or 1, within the treatment area) on the PGA of disease severity
次要结局
未报告次要终点