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New treatment option for Burn Injury
Official title Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
ClinicalTrials.gov ID: NCT05856994
What this study is testing
What is Tacrolimus ointment?
Tacrolimus ointment is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for burn injury.
Also referred to as Protopic® ointment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join 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...
You likely can't join 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...
- Subject is incarcerated.
- Friction, chemical or electric burn etiology.
See the full eligibility 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...
- 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.