Bovine Atelocollagen for Healthy Subjects

Overseen By Stefan M Lemperle, MD, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AscentX Medical, Inc.

Must not be taking: Immuno-suppressants, Cortico-steroids

Disqualifiers: Pregnancy, Skin disease, Immuno-suppressants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

Who Is on the Research Team?

Peter Rullan, MD

Principal Investigator

Dermatology Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects willing and able to comply with the follow-up requirements.

Subjects willing and able to give written and verbal informed consent.

Volunteers must be capable of understanding and following directions in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intradermal injections of atelocollagen on Day 01 and Day 15

2 weeks

2 visits (in-person)

Follow-up

Final assessment of injection sites and monitoring for hypersensitivity reactions

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bovine Atelocollagen

How Is the Trial Designed?

Group I: Bovine Atelocollagen Skin Sensitization Test Experimental Treatment 1 Intervention

Volunteer cohort tested for hypersensitivity towards intradermal injection of bovine atelocollagen.

Who Is Running the Clinical Trial?

AscentX Medical, Inc.

Lead Sponsor

Trials

1

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11396097/

An Evaluation of Skin and Immunological Responses after ...

3.1.​​ Of the 256 evaluated participants, there were no positive skin allergy results in the FULLSGEN group (0/124, 0.0%), whereas two FACIALGAIN ...

2.

withpower.com

withpower.com/trial/phase-healthy-subjects-hs-2022-084af

Bovine Atelocollagen Skin Sensitization Test

What data supports the effectiveness of the treatment Bovine Atelocollagen? Research shows that atelocollagen can help with wound healing in various ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/2584456/

Reactions to a bovine collagen implant. Clinical and ...

We found a strong correlation between the presence of antibodies to collagen and a positive response to skin testing (92%) or an adverse reaction (100%). In the ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0190962287701200

Immune responses to bovine collagen implants

In this study we examined the levels of anti-bovine collagen implant antibodies in 150 individuals prior to bovine collagen implant therapy and then monitored ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05235087/bovine-atelocollagen-skin-sensitization-test

Bovine Atelocollagen Skin Sensitization Test

Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device ...

6.

mdpi.com

mdpi.com/2073-4360/15/4/1020

An Update on the Clinical Efficacy and Safety of Collagen ...

Allergy to bovine derived collagen is genetically regulated by the lack of the HLA-DR4 antigen [234]. To avoid allergic reaction, skin testing now is mandatory.