NCT02576847已完成3 期
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
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
- 307
- 主要终点
- Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
研究概览
简要总结
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male and nonpregnant female subjects, 18 years of age or older.
- •A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
- •Subjects with the presence of telangiectasia at Baseline
- •Subjects with the presence of facial erythema associated with their rosacea at Baseline
排除标准
- •Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- •Subjects with nodular rosacea
- •Standard exclusion criteria.
研究组 & 干预措施
Treatment
Experimental
Omiganan gel applied once daily
干预措施: Omiganan (Drug)
结局指标
主要结局
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
时间窗: Up to 12 months
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
次要结局
未报告次要终点
研究者
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