Bovine Atelocollagen Skin Sensitization Test
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Hypersensitivity Evaluation
研究概览
简要总结
Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants
详细描述
Day 01: Receive 0.1 mL intradermal injection of atelocollagen skin test into left volar forearm.
Day 15: Receive 2nd intradermal injection of 0.1 mL atelocollagen skin test into right volar forearm (14 days after 1st injection).
Day 45: Final assessment of both injection sites (30 days after 2nd injection)
Note: ALL injection sites will be assessed clinically at 30 minutes (for observational purposes) and at 72 hours (to determine response) after each injection. Visit windows for 72 hour assessments, and Day 15 and Day 45 visits can occur up to 96 hours (4 days) after target time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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, of either sex, aged at least 18 years.
- •Volunteers must be capable of understanding and following directions in English.
- •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.
- •Current treatment by a physician for allergy, unless physician consulted by Investigator and participation was approved.
- •Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month.
- •Recent immunization, including COVID-19 (less than 14 days prior to skin test).
- •Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
- •Subjects with medical history indicating atopy or dermatographia ('skin writing').
- •Subject has a current skin disease of any type apart from mild facial acne (e.g., eczema, psoriasis).
- •Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
- •Subjects who were or are currently being treated with any systemic immuno-suppressive therapy, including but not limited to chemotherapy agents or cortico-steroids (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.
结局指标
主要结局
Hypersensitivity Evaluation
时间窗: 44 days
Subjects will monitor the implant sites daily for signs of local reactions and are instructed to record other clinical symptoms occurring during the course of the study. Unscheduled visits will be secured if subjects report adverse events between scheduled visits. Hypersensitivity to the xenogenic collagen test material will be assessed through visual scoring by trained clinical staff, a qualified physician, and subject diary observations. All potential reactions will be photographed by study staff for scoring confirmation. Hypersensitivity reaction will be assessed based on FDA's recent draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. A positive response is defined as a skin response greater than Score 2 of 4 mm diameter at the implant site persisting more than 72 hours, with photograph, and verification of an immune reaction by histopathology of the site biopsy.
次要结局
未报告次要终点