Bovine Atelocollagen Skin Sensitization Test

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.