A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-400 Topical Gel for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 13
- 主要终点
- Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.
研究概览
简要总结
This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).
详细描述
Study to assess the efficacy and safety of CLE-400 topical gel applied once daily for the treatment of moderate-severe chronic pruritus in adult subjects with NP. The study comprises a screening phase of up to 37 days, including a 7-day run-in period, a 4-week double-blind treatment period, and a 2-week follow-up period.
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)
盲法说明
double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a confirmed diagnosis of Notalgia Paresthetica.
- •Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica.
- •Subject has moderate to severe pruritus.
- •Subject is able and competent to read and sign the informed consent form (ICF).
排除标准
- •Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica.
- •Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results
- •Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
研究组 & 干预措施
CLE-400 (Detomidine topical gel)
Topical CLE-400 gel 0.28% once daily
干预措施: CLE-400 (Drug)
Vehicle
Topical vehicle gel once daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.
时间窗: Baseline, Week 4 (28 days).
The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable.
次要结局
未报告次要终点