GF-001001-00 Cream.A Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of 3 Different Doses of GF-001001-00 Cream Versus Placebo Cream Applied 2 Times Daily for 7 Days in the Treatment of Adult Patients With Secondarily-infected Traumatic Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
详细描述
200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo).
Randomised patients will apply the study medication as follows depending on their assigned treatment group.
- GF-001001-00 2%, 2 times daily, for 7 days
- GF-001001-00 1%, 2 times daily, for 7 days
- GF-001001-00 0.25%, 2 times daily, for 7 days
- Placebo, 2 times daily, for 7 days
The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment).
Primary objective:
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
- 否
入选标准
- •Males and females ≥ 18 years of age.
- •Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
排除标准
- 未提供
研究组 & 干预措施
GF-001001-00 2%
干预措施: GF-001001-00 (Drug)
GF-001001-00 1%
干预措施: GF-001001-00 (Drug)
GF-001001-00 0.25%
干预措施: GF-001001-00 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical cure
时间窗: Day 14
次要结局
- Microbiological cure(Day 14)
- Adverse events Clinical laboratory parameters Vital signs(Day 14)