Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns (NCT05856994) | Clinical Trial Compass
RecruitingPhase 1
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
United States18 participantsStarted 2024-09-19
Plain-language 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.
Who can participate
Age range50 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Immunos…