Bovine Atelocollagen Skin Sensitization Test

Study Overview
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Brief Summary
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Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants

Detailed Description
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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.

Official Title
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Bovine Atelocollagen Skin Sensitization Test

Conditions
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Healthy

Intervention / Treatment
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* Device: Bovine atelocollagen intradermal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine Atelocollagen Skin Sensitization Test<br>Volunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen. | Device: Bovine atelocollagen intradermal injection<br>* Intradermal skin test injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity Evaluation | 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. | 44 days |