Protopic® Ointment for Burns
What You Need to Know Before You Apply
What is the purpose of this trial?
There is currently no standard treatment to prevent burn depth conversion in partial-thickness burns. Conversion into deeper wounds is associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Therefore, the investigators propose testing the safety and efficacy of tacrolimus ointment (an immunosuppressive agent) in patients with deep partial-thickness burns.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on medications that cause immunosuppression or require aggressive treatment for infections, you may not be eligible to participate.
Is Protopic® Ointment (Tacrolimus) generally safe for use in humans?
How is the drug Protopic® Ointment unique for treating burns?
Protopic® Ointment (tacrolimus) is unique because it is primarily used for skin conditions like atopic dermatitis and works by suppressing the immune response, which may help reduce inflammation in burns. Unlike standard burn treatments that focus on infection prevention and wound healing, tacrolimus targets the immune system to potentially reduce inflammation.12367
What data supports the effectiveness of the drug Protopic® Ointment for treating burns?
Who Is on the Research Team?
Wesley Thayer, MD, PhD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for men and women aged 50-75 with deep partial-thickness burns on their hands, covering ≤5% of their body. They must be able to start treatment within 24-48 hours after the burn and commit to the study's duration. Exclusions include pregnancy, breastfeeding, certain infections or conditions that affect safety/data quality, immunosuppression, prior treatments or studies involving the burn wound(s), allergies to tacrolimus or bacitracin.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tacrolimus ointment or other standard treatments for deep partial-thickness burns
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tacrolimus Ointment
Tacrolimus Ointment is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor