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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Tacrolimus

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.