A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED, DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE TREATMENT OF INCISION SCARS IN THE PANNUS OF SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Part B: Expert Panel Scar Assessment Score
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
- 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 45 Years（Adult）
- 性别
- Female
- 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
- •Subjects with existing scars or significant striae on the abdominal pannus
- •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
干预措施: EXC 001 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Part B: Expert Panel Scar Assessment Score
时间窗: Week 13 of Part B
Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13.
次要结局
- Part B: Physician Observer Global Assessment Scar Score(Week 13 of Part B)
- Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Part B: Day 1 up to Week 14)
- Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings(Part B: Day 1 up to Week 14)
- Part A and B: Number of Participants With Positive Skin Sensitivity Reaction(From Day 21 of Part A up to Week 2 of Part B)
- Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings(Week 13 of Part B)
- Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings(Part B: Day 1 up to Week 13)