Can a common ointment stop burns from getting worse?
NCT ID NCT05856994
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This early-stage trial tests whether tacrolimus ointment (Protopic) can prevent deep partial-thickness burns from worsening. Researchers believe the drug may calm the inflammation that often makes burns deeper. The study will enroll 18 adults aged 50 to 75 with burns on their hands and compare the ointment to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tacrolimus ointment (Protopic)
- What this could lead to
- If it works, this could point toward a new way to prevent burns from getting deeper, reducing complications and improving healing.
- What could go wrong
- This is a very early Phase 1 trial with only 18 people, so results may not apply widely. The ointment is an immunosuppressant, which could increase infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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1 person
The number who actually took part.
- Started
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Sep 2024
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provision of signed and dated informed consent form by the subject or Legally Authorized Representative. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female aged 50 to 75 at time of screening visit. * For females of reproductive potential, confirmed negative urine pregnancy test at enrollment. * Presence of deep partial-thickness burns to one or both dorsal hands (burns may be present on other areas of the body, so long as all regions combined are ≤ 5% Total Body Surface Area \[TBSA\], using the Browder and Lund Chart). * Thermal burn (caused by fire, hot objects, steam or hot liquids \[scalding\]) etiology, located on one or both dorsal hands. * Ability to implement treatment within 24-48 hours days of the initial burn. Exclusion Criteria: * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Allergy or hypersensitivity to tacrolimus or other components of the ointment (per subject report) or personal preference. * Allergy or hypersensitivity to bacitracin and/or any of its drug formulation components. Patients with known hypersensitivity to neomycin may also be sensitive to bacitracin. * Subject is incarcerated. * Friction, chemical or electric burn etiology. * Immunosuppression, as determined by the Principal Investigator. * Presence of a local and/or systemic infection that, in the Investigator's opinion, requires aggressive treatment which would warrant exclusion from participating in this study. * Subject is unwilling or unable to follow study related procedures and/or follow-up visits. * Prior treatment to the burn wound(s) on the hand(s) considered for this trial with another product (treatment failure). * Subject report of previous participation in another interventional burn wound study within 60 days prior to the Screening Visit. * Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. * The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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