A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
研究概览
简要总结
To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.
详细描述
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the Treatment of Moderate to Severe 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
- •Subjects must have provided IRB approved written informed consent
- •Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
- •Subjects with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving at least 3% and no more than 12% of the body surface area (BSA). Affected areas should not include the axillae, face, scalp, soles, palms, and intertriginous areas
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- •Subjects with a known hypersensitivity to tazarotene, halobetasol propionate, other corticosteroids, or to any ingredients in the study drugs.
- •Subjects with current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
研究组 & 干预措施
Halobetasol Propionate and Tazarotene Topical lotion 0.01%/0.045%
The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks
干预措施: Halobetasol Propionate and Tazarotene Lotion 0.01%/0.045% (Drug)
Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045%
The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks
干预措施: Duobrii® Lotion (Halobetasol propionate and tazarotene lotion), 0.01%/0.045% (Drug)
Placebo Control
The study drug is to be self-administered by applying as a thin layer once daily to cover only affected areas and rubbed in gently for approximately 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of subjects with a response of "treatment success" on the IGA of disease severity at Week 8
时间窗: Week 8
次要结局
未报告次要终点