A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 601
- 试验地点
- 69
- 主要终点
- Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
研究概览
简要总结
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
详细描述
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.
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
- 9 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed 12 weeks of treatment in NI-AC301 or NI-AC302
排除标准
- •Terminated early from an SB204 Phase 3 pivotal study for any reason
- •Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
- •Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
研究组 & 干预措施
SB204 4%
All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.
干预措施: SB204 4% (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
时间窗: Baseline
This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Number of Subjects With Treatment Emergent Adverse Events
时间窗: Week 40/End of Treatment
Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.
次要结局
- Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)(Baseline, Week 4, Week 12, Week 24, Week 36, Week 40)
- Inflammatory Lesion Counts by Study Visit(Baseline through Week 40)
- Non-Inflammatory Lesion Counts by Study Visit(Baseline through Week 40)