An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- number of participants with adrenal suppression
研究概览
简要总结
An Open-Label study to assess safety
详细描述
An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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.
- •Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
- •Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.
研究组 & 干预措施
Topical TA-102 A
A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
干预措施: Topical TA-102 A (Drug)
Topical TA-102 B
A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
干预措施: Topical TA-102 B (Drug)
Topical TA-102 C
A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
干预措施: Topical TA-102 C (Drug)
Topical TA-102 D
A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
干预措施: Topical TA-102 D (Drug)
Topical TA-102 E
A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily
干预措施: Topical TA-102 E (Drug)
结局指标
主要结局
number of participants with adrenal suppression
时间窗: 84 Days
number of participants with adrenal suppression developed during the treatment with the study drug
次要结局
未报告次要终点