Testing tacrolimus ointment for treating deep partial-thickness burns

Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns

This study is testing if tacrolimus ointment can help heal deep partial-thickness burns and prevent them from getting worse.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT05856994 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of tacrolimus ointment in patients with deep partial-thickness burns. The study aims to prevent the conversion of superficial partial-thickness burns into deeper wounds, which can lead to increased complications and morbidity. Participants will be closely monitored for their response to the treatment, which is theorized to reduce inflammation and improve healing outcomes. The trial will involve a multidisciplinary team to ensure comprehensive care for the complex needs of burn patients.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 50 to 75 with deep partial-thickness burns on one or both dorsal hands.

Not a fit: Patients with burns covering more than 5% of their total body surface area or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes and reduce complications for patients with deep partial-thickness burns.

How similar studies have performed: This approach is novel, as there has yet to be a clinical study investigating the use of tacrolimus in burn treatment.

Eligibility criteria

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.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Wesley Thayer, MD, PhD — Vanderbilt University Medical Center
• Study coordinator: Wesley Thayer, MD, PhD

Conditions: Burn Injury