NCT01037985已完成2 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE AMELIORATION OF SCARRING OF THE SURGICAL INCISION IN SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY
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
- Pfizer
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Expert Panel Scar Assessment Score at Week 12: Part B
研究概览
简要总结
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
- •Subject has chosen to have an elective abdominoplasty
- •Medically healthy with normal screening results
- •Subjects must not be pregnant or lactating
排除标准
- •Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
- •Participation in another clinical trial within 30 days prior to the start of the study
- •Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
研究组 & 干预措施
EXC 001
Experimental
干预措施: EXC 001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Expert Panel Scar Assessment Score at Week 12: Part B
时间窗: Week 12
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar. A pair of photographs for each participant were presented and evaluated 3 times by an expert panel.
次要结局
- Expert Panel Scar Assessment Score at Week 24: Part B(Week 24)
- Physician Observer Scar Assessment Score at Week 12 and 24: Part B(Week 12 and 24)
- Participants Observer Scar Assessment Score at Week 12 and 24: Part B(Week 12 and 24)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 of Part A up to Week 24 of Part B)
- Number of Participants With Abnormal Physical Examinations Findings: Part A and Part B(Day 1 of Part A up to Week 12 of Part B)
- Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG): Part A and Part B(Day 1 of Part A up to Week 12 of Part B)
- Number of Participants With Clinically Significant Findings in Laboratory Examinations: Part A and Part B(Day 1 of Part A up to Week 12 of Part B)
- Number of Participants With Positive Skin Sensitivity Reaction: Part A and Part B(Day 21 of Part A up to Day 14 of Part B)
- Number of Participants With Clinically Significant Findings in Vital Signs and Weight: Part A and Part B(Day 1 of Part A up to Week 12 of Part B)
研究者
研究点 (6)
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