NCT03127956已完成3 期
An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 748
- 试验地点
- 92
- 主要终点
- Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
研究概览
简要总结
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent or assent (for subjects under legal adult age)
- •Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
- •Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
- •Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.
排除标准
- •Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
- •Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
研究组 & 干预措施
Olumacostat Glasaretil Gel, 5.0%
Experimental
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
干预措施: Olumacostat Glasaretil Gel, 5.0% (Drug)
结局指标
主要结局
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
时间窗: Day 1 - Week 36
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
次要结局
未报告次要终点
研究者
研究点 (92)
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