A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 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
- 60
- 试验地点
- 1
- 主要终点
- Cutaneous tolerability Evaluation
研究概览
简要总结
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
详细描述
This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).
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
- Single (Investigator)
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 female volunteers
- •Age 18 or older
- •High degree of fluorescence of facial skin under Wood's lamp
排除标准
- •Acute or chronic skin disorders
- •Use of topical or systemic antibiotics within 4 weeks of study
- •Concomitant use of nitroglycerin or other nitric oxide donor drugs
- •Females who are pregnant, planning pregnancy or breast feeding
研究组 & 干预措施
8% NVN1000 Topical Gel
8% NVN1000 8% Topical Gel applied once daily for 4 weeks
干预措施: 8% NVN1000 Topical Gel (Drug)
2% NVN1000 Topical Gel
2% NVN1000 Topical Gel once daily for 4 weeks
干预措施: 2% NVN1000 Topical Gel (Drug)
4% NVN1000 Topical Gel
4% NVN1000 4% Topical Gel once daily for 4 weeks
干预措施: 4% NVN1000 Topical Gel (Drug)
Vehicle Topical Gel
Vehicle Topical Gel once daily for 4 weeks
干预措施: Vehicle Topical Gel (Drug)
结局指标
主要结局
Cutaneous tolerability Evaluation
时间窗: 4 weeks
Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).
次要结局
- Safety Assessment(4 weeks)