NCT04070755已完成1 期
A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo 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
- 56
- 主要终点
- Assessment of photoallergic skin reactions (numerical equivalent scoring of erythema and edema) after periodic exposure to IP on irradiated and non-irradiated skin
研究概览
简要总结
A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo 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 male or female who were 18 years of age or older
- •Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III
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
Assessment of photoallergic skin reactions (numerical equivalent scoring of erythema and edema) after periodic exposure to IP on irradiated and non-irradiated skin
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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