NCT04064125已完成1 期
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.
研究概览
简要总结
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females who were 18 years of age or older.
- •Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema.
排除标准
- •Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction.
- •Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
研究组 & 干预措施
FMX-101
Experimental
干预措施: FMX-101 (Drug)
结局指标
主要结局
Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
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