A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 103
- 试验地点
- 39
- 主要终点
- Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have hypertrophic (raised) breast scars from previous surgery
- •Subjects must be healthy
排除标准
- •Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding.
- •Presence of history of breast cancer
研究组 & 干预措施
Group 1
干预措施: PF-06473871 (Drug)
Group 2
干预措施: PF-06473871 (Drug)
结局指标
主要结局
Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
时间窗: Week 24
Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.
次要结局
- Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)(Week 8, 11, 18, 24)
- Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)(Week 8, 11, 18, 24)
- Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score(Week 8, 24)
- Physician and Participant Photoguide Scar Assessment Scale Score(Week 8, 11, 18, 24)