A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- The absolute change from baseline in non-inflammatory lesion counts at Week 12
研究概览
简要总结
This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.
详细描述
This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
- •Baseline IGA score of mild, moderate or severe
- •Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit
排除标准
- •Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
- •Female subjects who are pregnant, nursing, or considering becoming pregnant
- •Methemoglobin > 2% at baseline
- •Clinically significant anemia at baseline
- •Use of topical or systemic medications to treat acne
- •Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
研究组 & 干预措施
NVN1000 1% Gel
NVN1000 1% Gel twice daily
干预措施: NVN1000 1% Gel (Drug)
NVN1000 4% Gel
NVN1000 4% Gel twice daily
干预措施: NVN1000 4% Gel (Drug)
Vehicle Gel
Vehicle Gel twice daily
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
The absolute change from baseline in non-inflammatory lesion counts at Week 12
时间窗: 12 weeks
The absolute change from baseline in non-inflammatory lesion counts at Week 12
次要结局
- The absolute change from baseline in inflammatory lesion counts at Week 12(12 weeks)
- Success on the Investigator Global Assessment (IGA) at Week 12(12 week)