Status:
WITHDRAWN
Bovine Atelocollagen Skin Sensitization Test
Lead Sponsor:
AscentX Medical, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05235087
Start Date
May 1 2023
End Date
December 1 2023
Last Update
August 1 2024
Active Locations (1)
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1
Dermatology Institute
Chula Vista, California, United States, 91910