A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 13
- 主要终点
- Evaluator Live Acne Scarring Assessment Responders
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female, between 18 years and 65 years of age.
- •Investigator assessment of the acne scarring on each cheek of moderate to severe.
- •A history of acne scarring for more than 3 years.
- •Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.
排除标准
- •Significant active acne.
- •Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
- •Presence of hypertrophic scars on the cheeks.
- •More than 20% of treatment area comprised of ice pick scars or sinus tracts
- •Treatment area per cheek is less than 9 cm x cm
- •Unilateral or unbalanced acne scar distribution.
- •Physical attributes which prevent the assessment or treatment of the acne scars.
- •Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
- •Previous treatment with Isolagen TherapyTM.
- •Use of Isotretinoin within one year of enrollment into study.
- •Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
- •Disorders or drugs that increase bleeding or clotting.
- •Pregnant or lactating women or women trying to become pregnant during the study.
- •Excessive exposure to sun.
- •Smoking more than ½ pack of cigarettes per day.
结局指标
主要结局
Evaluator Live Acne Scarring Assessment Responders
时间窗: Baseline (prior to first treatment) and four months after last treatment
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Subject Live Acne Scarring Assessment Responders
时间窗: Baseline (prior to first treatment) and four months after last treatment
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.
次要结局
- Evaluator Live Acne Scarring Assessment Responders(Baseline (prior to first treatment) compared to one, two, and three months after last treatment)
- Subject Live Acne Scarring Assessment Responders(Baseline (prior to first treatment) compared to one, two, and three months after last treatment)