NCT04070742已完成1 期
A 4-Day, Randomized, Controlled Study to Evaluate the Phototoxicity Potential of FMX-101, 4% in Healthy Volunteers
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
- 32
- 主要终点
- Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score
研究概览
简要总结
Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers
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 volunteers age 18 years or older
- •Has 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
- •Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
- •Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study
研究组 & 干预措施
FMX-101
Experimental
干预措施: FMX101 (Drug)
结局指标
主要结局
Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score
时间窗: 4 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Dermal Cumulative Irritant Patch StudyHealthyNCT04064125Vyne Therapeutics Inc.42
已完成
1 期
Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 CreamPhototoxicityNCT03892564MC2 Therapeutics35
已完成
1 期
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test DesignHealthyNCT04052711Vyne Therapeutics Inc.233
已完成
1 期
A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy VolunteersHealthyNCT03473184Castle Creek Pharmaceuticals, LLC34
已完成
1 期
Dermal Photo Allergic Skin ReactionHealthyNCT04070755Vyne Therapeutics Inc.56