NCT02250430已完成1 期
A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 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
- 发起方
- Novan, Inc.
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Duration of erythema following application of SB204 2% and SB204 4%.
研究概览
简要总结
In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.
详细描述
This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Women who are pregnant or nursing
- •Subject with known sensitivity to a component of the test materials
研究组 & 干预措施
Topical SB204
Experimental
Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3
干预措施: SB204 (Drug)
结局指标
主要结局
Duration of erythema following application of SB204 2% and SB204 4%.
时间窗: 3 days
Intensity of erythema following application of SB204 2% and SB204 4%.
时间窗: 3 days
次要结局
- pH on the surface of the skin after topical application of 2 concentrations of SB204(3 days)
研究者
研究点 (1)
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