A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cutaneous tolerability
研究概览
简要总结
A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
详细描述
This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 and Females > 18 years of age
- •High degree of fluorescence of facial skin under Wood's lamp
排除标准
- •Acute or chronic skin disorders
- •Topical or systemic antibiotics within 4 weeks of study enrollment
- •Use of medication that increases risk of methemoglobinemia or influences P. acnes counts
- •Subjects with medical illnesses, anemia, elevated methemoglobin
- •Women who are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
Topical Gel Vehicle
Once daily application of topical gel vehicle to forehead for 3 days
干预措施: Topical Gel Vehicle (Drug)
8% NVN1000 Topical Gel
Once daily application of 8% NVN1000 Topical Gel to the forehead for 3 days
干预措施: 8% NVN1000 Topical Gel (Drug)
8% NVN1000 Topical Gel and moisturizer
Once daily application of 8% NVN1000 Topical Gel to the forehead, followed 15 minutes later by application of a commercially available moisturizer
干预措施: 8% NVN1000 Topical Gel and moisturizer (Drug)
结局指标
主要结局
Cutaneous tolerability
时间窗: 3 days
Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.
次要结局
- Safety comparison(3 Days)