A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Percent Change in EASI From Baseline at Day 29
研究概览
简要总结
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent or adult subject aged 12 - 65 years.
- •Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA
排除标准
- •AD with known hypersensitivity to excipients of TER-101 Ointment
- •Subjects who are immunocompromised
研究组 & 干预措施
TER-101
BID (twice daily) application
干预措施: TER-101 (Drug)
Vehicle
Vehicle ointment, BID (twice daily) application
干预措施: Vehicle (Drug)
结局指标
主要结局
Percent Change in EASI From Baseline at Day 29
时间窗: 29 days
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
次要结局
- Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD(29 days)
- Changes in EASI Over Time(15 days)
- Change in IGA From Baseline Over Time(29 Days)
- Changes in Itch Over Time(29 days)