Burn InjuryPhase 1NCT05856994
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
A Phase 1 study testing Tacrolimus ointment in people with Burn Injury, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Tacrolimus ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to 20 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
Patients who sustain burn injuries are some of the most complex patients to care for, often requiring a multidisciplinary team of providers specialized in burn pathophysiology. While many facets of burn care must be accounted for including fluid management, nutrition, respiratory status, immunologic and cardiovascular function, innovation in the treatment for deep partial thickness burns is of paramount importance.
Burn depth conversion is a phenomenon where superficial partial-thickness burns spontaneously convert into deep partial-thickness or full-thickness burns, which are associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Excess inflammation worsens the injury through various mechanisms, including cytokine production, delayed inflammatory cell apoptosis, and reactive oxidative species production.
Protopic® (tacrolimus) Ointment is a macrolide immunosuppressant and a calcineurin inhibitor. Tacrolimus inhibits T-lymphocyte activation, a key cell in the body's immune response. A prolonged inflammatory response is theorized to contribute to a worse recovery outcome in partial- to full-thickness burns. Therefore, tacrolimus possesses properties that could slow the acute inflammatory response and potentially improve clinical outcomes in deep partial-thickness burns. There has yet to be a clinical study to investigate the use of tacrolimus in burn treatment. However, our group recently published an animal study that found a significant reduction in burn depth using tacrolimus topically (White-Dzuro et al. Burns 2022). This study is a randomized clinical trial of the usage of tacrolimus ointment for the treatment of deep partial-thickness burns with comprehensive assessments of healing and functional outcomes.
- Conditions
- Burn Injury
- Being tested
- Tacrolimus ointment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
Also called Protopic® ointment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound healing
Clinical burn wound assessment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start19 Sep 2024
- Primary completion12 Jan 2026
- Study completion20 Apr 2026
Why it stopped: PI departure from institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Thayer, Vanderbilt University Medical Center
- Investigators
- Wesley Thayer, MD, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856994
- Sponsor's protocol ID
- 222242
- Status last verified
- Jul 2026
- First submitted
- 3 May 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
- ClinicalTrials.gov ID
- NCT05856994
- Acronym / sponsor ID
- 222242
- Conditions
- Burn Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI departure from institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who sustain burn injuries are some of the most complex patients to care for, often requiring a multidisciplinary team of providers specialized in burn pathophysiology. While many facets of burn care must be accounted for including fluid management, nutrition, respiratory status, immunologic and cardiovascular function, innovation in the treatment for deep partial thickness burns is of paramount importance.
Burn depth conversion is a phenomenon where superficial partial-thickness burns spontaneously convert into deep partial-thickness or full-thickness burns, which are associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Excess inflammation worsens the injury through various mechanisms, including cytokine production, delayed inflammatory cell apoptosis, and reactive oxidative species production.
Protopic® (tacrolimus) Ointment is a macrolide immunosuppressant and a calcineurin inhibitor. Tacrolimus inhibits T-lymphocyte activation, a key cell in the body's immune response. A prolonged inflammatory response is theorized to contribute to a worse recovery outcome in partial- to full-thickness burns. Therefore, tacrolimus possesses properties that could slow the acute inflammatory response and potentially improve clinical outcomes in deep partial-thickness burns. There has yet to be a clinical study to investigate the use of tacrolimus in burn treatment. However, our group recently published an animal study that found a significant reduction in burn depth using tacrolimus topically (White-Dzuro et al. Burns 2022). This study is a randomized clinical trial of the usage of tacrolimus ointment for the treatment of deep partial-thickness burns with comprehensive assessments of healing and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Ointment 0.03% with hydrocolloid dressing | Experimental | Drug: Tacrolimus ointmentStandard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area. |
| 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus ointmentAlso: Protopic® ointmentFor 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. | Drug | Tacrolimus Ointment 0.03% with hydrocolloid dressing |
Primary outcome
Time to complete wound healing
Time frame: 21 days
Clinical burn wound assessment
Results and safety
The study was stopped early (reason given: PI departure from institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Thayer, MD, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tacrolimus ointment in people with Burn Injury, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI departure from institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound healing (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.