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

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 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.
• * 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.