Actively Recruiting
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Led by Vanderbilt University Medical Center · Updated on 2025-10-20
18
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form by the subject or legally authorized representative
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 50 to 75 years at screening
- For females of reproductive potential, a confirmed negative urine pregnancy test at enrollment
- Presence of deep partial-thickness burns on one or both dorsal hands, with total burns on the body of 5% or less
- Thermal burns caused by fire, hot objects, steam, or hot liquids located on one or both dorsal hands
- Ability to start treatment within 24 to 48 hours after the initial burn
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control if applicable
- Any condition or abnormality that compromises patient safety or data quality as judged by the investigator
- Allergy or sensitivity to tacrolimus or ointment components
- Allergy or sensitivity to bacitracin or its components; known neomycin allergy may also apply
- Incarceration
- Burns caused by friction, chemicals, or electricity
- Immunosuppression as determined by the principal investigator
- Local or systemic infection requiring aggressive treatment
- Inability or unwillingness to follow study procedures or attend follow-up visits
- Prior treatment of the burn wounds with another product considered a treatment failure
- Participation in another interventional burn wound study within 60 days before screening
- Concurrent participation in another clinical trial involving investigational drugs or devices that interfere with this study
- Any physical or psychiatric condition that could prevent study completion or warrant exclusion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
W
Wesley Thayer, MD, PhD
CONTACT
J
Julia Yao, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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