NCT03429595已完成2 期
Randomized, Double-Blind, Vehicle Controlled, Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of Topical ATx201 GEL (2% and 4%) in Outpatients With Impetigo
UNION therapeutics3 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2018年2月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Incidences of Adverse Events and Laboratory Parameters
研究概览
简要总结
This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.
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
- 9 Months 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of primary nonbullous or bullous impetigo
- •affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.
- •target area has total SIRS score of at least 3, including pus/exudate of at least 1
- •normally active and otherwise in good health by medical history and physical examination
排除标准
- •has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection
- •has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy
- •clinically significant mental illness
- •pregnant or breast-feeding
- •recent history, or strong potential for, alcohol or substance abuse.
- •skin condition that may interfere with the placement of study treatment or impede clinical evaluations
- •receipt of systemic drugs that affect the immune system within the past 3 months
- •receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours
研究组 & 干预措施
Group 1: ATx201 GEL 2%
Experimental
干预措施: ATx201 (Drug)
Group 2: ATx201 GEL 4%
Experimental
干预措施: ATx201 (Drug)
Group 3: ATx201 GEL 4% plus vehicle
Experimental
干预措施: ATx201 (Drug)
Group 3: ATx201 GEL 4% plus vehicle
Experimental
干预措施: ATx201 GEL Vehicle (Other)
Group 4: ATx201 GEL 4% plus vehicle
Experimental
干预措施: ATx201 (Drug)
Group 4: ATx201 GEL 4% plus vehicle
Experimental
干预措施: ATx201 GEL Vehicle (Other)
Group 5: Vehicle
Placebo Comparator
干预措施: ATx201 GEL Vehicle (Other)
结局指标
主要结局
Incidences of Adverse Events and Laboratory Parameters
时间窗: 14 days
incidences of adverse events reports and changes in significant laboratory parameters
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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