An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluating skin irritation with Mean Irritation Score (MIS)
研究概览
简要总结
This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.
详细描述
This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent prior to entering the study or undergoing any study procedures;
- •Subject is a generally healthy male or female 18 to 65 years of age;
- •Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.
排除标准
- •Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
- •Subject has severe cardiac, renal or hepatic impairment;
- •Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.
研究组 & 干预措施
HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously.
干预措施: HP-5000 Topical Patch (Drug)
HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously.
干预措施: HP-5000 Placebo Patch (Drug)
HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously.
干预措施: Saline Patch (Drug)
结局指标
主要结局
Evaluating skin irritation with Mean Irritation Score (MIS)
时间窗: 21 days
To evaluate skin irritation after exposure to HP-5000, placebo and saline.
Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics
时间窗: 21 days
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
次要结局
未报告次要终点