Bovine Atelocollagen for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test for potential allergic reactions to bovine atelocollagen, a medical device implant made from cow collagen. Researchers seek to determine if healthy adults might experience skin sensitivity when this substance is injected under the skin. It is suitable for healthy adults who can read and follow instructions in English and have normal skin on the inside of their forearm. Participants should not have any current skin diseases or allergies to beef or cow collagen. As an unphased trial, this study allows participants to contribute to important research on skin sensitivity and medical device safety.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on any systemic immuno-suppressive therapy or topical treatments on your arms, you may not be eligible if you've used them in the past 3 months.
What prior data suggests that this device is safe for skin testing?
Research has shown that some people can have allergic reactions to bovine atelocollagen, a type of collagen from cows often used in medical implants. The body may perceive the collagen as a foreign substance and create antibodies against it, leading to negative reactions. Studies suggest that many people, especially those lacking a specific genetic marker called HLA-DR4, might react to bovine atelocollagen. To lower the risk of an allergic reaction, doctors often recommend skin tests before using products with bovine collagen. These tests help identify individuals more likely to have a reaction. In summary, while bovine atelocollagen is used in medical treatments, checking for sensitivity first is important due to the possibility of allergic reactions.12345
Why are researchers excited about this trial?
Researchers are excited about bovine atelocollagen because it offers a novel approach to skin treatments. Unlike traditional options that often rely on synthetic ingredients or human-derived collagen, this treatment uses collagen from cows, which could reduce the risk of rejection and allergic reactions. Additionally, the unique atelocollagen structure is designed to integrate smoothly with human tissue, potentially enhancing skin repair and regeneration. This could make it a promising option for those who have sensitivities to current treatments.
What evidence suggests that this device is effective for detecting allergies?
Research has shown that bovine atelocollagen, tested in this trial, is generally safe with a low risk of causing allergies. In one study, none of the 124 participants experienced an allergic skin reaction. Atelocollagen also aids in wound healing, indicating good acceptance by the body. Another study found that only a few people developed antibodies, proteins that can lead to allergies, after collagen exposure. Overall, evidence suggests that bovine atelocollagen is unlikely to cause significant allergic reactions in most people.12456
Who Is on the Research Team?
Peter Rullan, MD
Principal Investigator
Dermatology Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intradermal injections of atelocollagen on Day 01 and Day 15
Follow-up
Final assessment of injection sites and monitoring for hypersensitivity reactions
What Are the Treatments Tested in This Trial?
Interventions
- Bovine Atelocollagen
Find a Clinic Near You
Who Is Running the Clinical Trial?
AscentX Medical, Inc.
Lead Sponsor