A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- Physician Observer Scar Assessment Score at Week 24
研究概览
简要总结
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have previous had breast surgery resulting in unacceptable scars.
- •Subject has chosen to have breast scars revised.
- •Subject must not be pregnant or lactating.
排除标准
- •Currently pregnant or pregnant during the 6 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 the study.
研究组 & 干预措施
Group 1
干预措施: EXC 001 (Drug)
Group 2
干预措施: EXC 001 (Drug)
Group 3
干预措施: EXC 001 (Drug)
Group 4
干预措施: EXC 001 (Drug)
结局指标
主要结局
Physician Observer Scar Assessment Score at Week 24
时间窗: Week 24
Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
次要结局
- Physician Observer Scar Assessment Score(Week 11, 18)
- Number of Participants With Physician Photonumeric Guide Scar Assessment Score(Week 24)
- Subject Observer Scar Assessment Score(Week 24)
- Number of Participants With Participant Photonumeric Guide Scar Assessment Score(Week 24)
- Expert Panel Scar Assessment Score(Week 11, 18, 24)