Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 498
- 试验地点
- 2
- 主要终点
- Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
研究概览
简要总结
The purpose of this study is to assess the clinical utility of the ArteFill® pre-treatment Skin Test in predicting and preventing hypersensitivity reactions to treatment with ArteFill® implant
详细描述
This is a single-center, open-label study in approximately 485 healthy male and female subjects to obtain 450 evaluable subjects. In this protocol, an ArteFill® Skin Test study will be conducted to evaluate the test's clinical utility to determine the incidence of positive skin reactions to ArteFill®. The results of this skin test study will determine if the risk of a hypersensitivity reaction against ArteFill® without a skin test is no greater than the published historical risk of a hypersensitivity reaction against a Zyderm or Zyplast treatment after a patient demonstrates a negative response to a single Zyderm skin test. Based on prior clinical experience with ArteFill® implant in commercial use outside the United States, it is anticipated that no reactions will be observed. As such, it may be suggested that there is no practical use of the ArteFill® Skin Test for screening patients, and therefore, the test may be eliminated as a requirement prior to treatment with the ArteFill® product as is the clinical practice outside the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years of age or older, male or female.
- •Subjects who are healthy and have normal skin on the volar surface of the forearm.
- •Subjects willing and able to comply with the requirements of the study.
- •Subjects willing and able to comply with the follow-up requirements.
- •Subjects willing and able to give written and verbal informed consent.
排除标准
- •Subjects who are pregnant, nursing or intend to become pregnant.
- •Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
- •Subjects who were or are currently being treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids (including inhaled or insufflated) within the past 3 months.
- •Subjects who were or are currently being treated with any topical OTC drug or prescription therapy on their arms (below the elbow) within the past 3 months.
- •Subjects with a history indicative of abnormal immune function (e.g. auto- immune diseases, HIV, cancer, etc).
- •Subjects with known lidocaine hypersensitivity.
- •Subjects with known sensitivity to bovine collagen.
- •Subjects who have a history of dietary beef allergy, undergoing desensitization to beef products or planning to undergo desensitization within the study evaluation period.
- •Subjects with severe allergies manifested by a history of anaphylaxis.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has received an investigational drug or an investigational device within 30 days prior to entering this study.
- •Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
研究组 & 干预措施
Open Label Single Arm
All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine.
干预措施: ArteFill® Skin Test (Device)
结局指标
主要结局
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
时间窗: 60 days
次要结局
- In addition to the primary outcome measure, to assist in assessing the etiology of the reaction, the immune response to the skin test in subjects with positive skin test will be evaluated by measuring serum antibody levels against bovine collagen.(60 days)