Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Wheal Formation
研究概览
简要总结
The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to cause an allergic response to healthy volunteers using a skin prick test.
详细描述
Using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. The test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. The skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy volunteers aged at least 18 years.
- •Completed written informed consent and receive a copy of their executed ICF.
- •Volunteers must be capable of understanding and following directions in English.
排除标准
- •Pregnancy or lactation;
- •Inadequate or non-existent contraception (women of child bearing potential only);
- •A current skin disease;
- •Heavy alcohol consumption;
- •Current use or history of repeated use of recreational drugs;
- •Recent illness prior to test;
- •Significant past medical history of diseases to potentially effect study results;
- •Current treatment of allergy;
- •A history of multiple drug hypersensitivity;
- •Concurrent medication likely to affect the response to the test articles or confuse the results of the study;
- •Known sensitivity to the test articles;
- •Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month;
- •Sensitization or questionable sensitization in a skin test;
- •Recent immunization.
研究组 & 干预措施
NeoMatriX and Two Comparators
NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)
干预措施: NeoMatriX Wound MatriX Collagen Dressing (Device)
结局指标
主要结局
Wheal Formation
时间窗: 15 minutes
Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).
次要结局
未报告次要终点