Skin Prick Test to Evaluate Allergenic Potential of a Collagen-Based Material in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Skin Prick Test Wheal Diameter
研究概览
简要总结
This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers
- •Age 18 to 70 years
- •Able to comply with study procedures
排除标准
- •Use of medications that may interfere with skin test responses
- •Known allergy to personal care products or adhesives
- •History of autoimmune disease
- •History of cancer
- •Uncontrolled chronic medical conditions
- •History of dermatographism
- •Known allergy to study materials
- •Known hypersensitivity to study materials
- •Active dermatitis or eczema at the test site
研究组 & 干预措施
Skin Prick Test Procedure
Participants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers.
干预措施: Collagen Matrix Skin Prick Test Device (Device)
结局指标
主要结局
Skin Prick Test Wheal Diameter
时间窗: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration
Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean wheal diameter at the test site in millimeters (mm).
Skin Prick Test Wheal Diameter Following Application of SILURCLOUD™ Fibrous Collagen Matrix
时间窗: 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration
Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean diameter of the wheal at the test site in millimeters (mm). A wheal ≥3 mm is considered a positive response. Wheal size will also be categorized using a 0-4 grading scale based on diameter.
次要结局
- Skin Prick Test Wheal Diameter in Participants With Fitzpatrick Skin Type VI Following Application of SILURCLOUD™ Fibrous Collagen Matrix(15 minutes, approximately 6 hours (±30 minutes), and 24-48 hours after skin prick test administration)