NCT05856994 Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
| NCT ID | NCT05856994 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Burn Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2024-09-19 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Wesley Thayer, MD, PhD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05856994 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Burn Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05856994 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05856994 currently recruiting?
Yes, NCT05856994 is actively recruiting participants. Contact the research team at wesley.thayer@vumc.org for enrollment information.
Where is the NCT05856994 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05856994 clinical trial?
NCT05856994 is sponsored by Vanderbilt University Medical Center. The principal investigator is Wesley Thayer, MD, PhD at Vanderbilt University Medical Center. The trial plans to enroll 18 participants.