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

NCT05856994 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 222242
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury

Outcome Measures

Primary Outcomes (1)

• Time to complete wound healing

  Clinical burn wound assessment

  21 days

Study Arms (3)

Tacrolimus Ointment 0.03% with hydrocolloid dressing

EXPERIMENTAL

Standard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area.

Drug: Tacrolimus ointment

Bacitracin ointment

NO INTERVENTION

Standard out-patient wound cleaning followed by application of bacitracin ointment over the burn and hydrocolloid dressing on the treated area.

Hydrocolloid dressing

NO INTERVENTION

Standard out-patient wound cleaning followed by application of hydrocolloid dressing on the burned area.

Interventions

Tacrolimus ointment DRUG

For the active comparator group, the wound(s) will be cleaned and bacitracin ointment will be applied to the wound. External dressings on all treated wounds will be placed based on the current standard of care. For the control group, the wound(s) will be cleaned and a hydrocolloid Dressing will be affixed to the burn and treated area. For the treatment group, the wound(s) will be cleaned and tacrolimus (0.03%) ointment will be applied over the burn. Hydrocolloid Dressing will be affixed to the burn and treated area. External dressings on all treated wounds will be placed based on the current standard of care.

Also known as: Protopic® ointment

Tacrolimus Ointment 0.03% with hydrocolloid dressing

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Wesley Thayer, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Thayer, MD, PhD

CONTACT

6159360160; wesley.thayer@vumc.org

Julia Yao, BSN

CONTACT

6153438426; jun.yao@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Plastic Surgery

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: September 19, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)