A Double Blind Study to Evaluate the Safety and Efficacy of Collagenase Clostridium Histolyticum (AA4500) in the Treatment of Lipoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Surface Area of the Lipoma at Six Months
研究概览
简要总结
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
详细描述
This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be observed similarly throughout the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years of age, of either sex or any race
- •Clinical history of at least 2 lipomas for at least one year
- •Lipomas diagnosed as benign
- •Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart, with easily definable edges
- •Each lipoma is a single mass with easily definable edges
- •Lipomas are 5 to 24 cm squared
- •Women of childbearing potential must use an acceptable method of birth control
排除标准
- •Lipomas on the head, neck, hand or foot, or female breast
- •Women who are nursing or pregnant
- •Multi-lobular lipomas
- •Subjects who have received an investigational drug within 30 days before receiving the first dose of study drug in this study
- •Subjects with a known allergy to collagenase or any of the inactive ingredients in XIAFLEX
- •Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical condition that would make the subject unsuitable for enrollment
- •Subjects having prior treatment or trauma of the lipoma that could interfere with study assessments
- •Subjects with a history of connective tissue diseases, rheumatological diseases
- •Subjects taking anticoagulants or planning to receive anticoagulants (except for lo dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days of injection of study drug
研究组 & 干预措施
AA4500
single injection of 0.58 mg study drug
干预措施: AA4500 (Drug)
Placebo
single injection of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Surface Area of the Lipoma at Six Months
时间窗: Baseline and 6 months post injection
The primary efficacy outcome is lipoma visible surface area defined as the longest dimension ("length") times the longest dimension perpendicular to length ("width"). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit.
次要结局
- Responder Analysis(Baseline and 6 months)
- Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months(Baseline and 6 months)
- Subject Satisfaction(6 months)