A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 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
- 30
- 试验地点
- 1
- 主要终点
- Tolerability based on the cutaneous tolerability scores
研究概览
简要总结
This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.
详细描述
In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.
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
- Double (Participant, 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 adult male or female volunteers
- •If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit
- •Agree to refrain from use of antimicrobial topical products during study
排除标准
- •Any skin disorders of acute or chronic nature including psoriasis, eczema, etc
- •Female subjects who are pregnant, nursing, or planning to become pregnant
- •Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors
- •Subjects with baseline methemoglobin > 2%
- •Subjects with clinically significant anemia
研究组 & 干预措施
NVN1000 4% Gel
NVN1000 4% Gel twice daily to the face for 2 weeks
干预措施: NVN1000 4% Gel (Drug)
Vehicle Gel
Vehicle Gel twice daily to the face for 2 weeks
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Tolerability based on the cutaneous tolerability scores
时间窗: 2 weeks
Cutaneous tolerability assessments (erythema, scaling, dryness, pruritus, burning/stinging) will be summarized with frequency counts and percentages at each score category for Week 1 and Week 2.
次要结局
- Safety which includes reported adverse events, clinically significant changes in physical exam, and labs(2 weeks)