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Immunosuppressive Agent

Protopic® Ointment for Burns

Phase 1
Recruiting
Led By Wesley Thayer, MD, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial will test if tacrolimus ointment can prevent conversion of partial-thickness burns to deeper wounds, reducing morbidity & complications.

Who is the study for?
This trial is for men and women aged 50-75 with deep partial-thickness burns on their hands, covering ≤5% of their body. They must be able to start treatment within 24-48 hours after the burn and commit to the study's duration. Exclusions include pregnancy, breastfeeding, certain infections or conditions that affect safety/data quality, immunosuppression, prior treatments or studies involving the burn wound(s), allergies to tacrolimus or bacitracin.Check my eligibility
What is being tested?
The trial tests Tacrolimus ointment's effectiveness in preventing deepening of partial-thickness burns. The goal is to see if this immunosuppressive agent can reduce complications by managing inflammation after a burn injury.See study design
What are the potential side effects?
Tacrolimus may cause side effects such as skin irritation at the application site, increased risk of infection due to immune suppression, and potential allergic reactions in those sensitive to its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to complete wound healing

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589
98%
Anemia
83%
Hypomagnesemia
75%
Leukopenia
70%
Hyperkalemia
57%
Abnormal renal function
50%
Hypophosphatemia
50%
Increase creatinine
45%
Hyperglycemia
33%
Delayed Graft Function Requiring Dialysis
30%
Diarrhea
30%
Nausea
28%
Headache
28%
Hypertension
25%
Tremor
25%
Infection
23%
Constipation
23%
Edema
20%
Vomiting
18%
Hyperlipidemia
18%
Hypokalemia
10%
Biopsy Proven Acute Rejection
8%
Neurotoxicity
3%
Graft loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYP3A5 Based Tacrolimus Dosing
Control

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tacrolimus Ointment 0.03% with hydrocolloid dressingExperimental Treatment1 Intervention
Standard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area.
Group II: Bacitracin ointmentActive Control1 Intervention
Standard out-patient wound cleaning followed by application of bacitracin ointment over the burn and hydrocolloid dressing on the treated area.
Group III: Hydrocolloid dressingActive Control1 Intervention
Standard out-patient wound cleaning followed by application of hydrocolloid dressing on the burned area.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus ointment
2019
N/A
~160

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
866 Previous Clinical Trials
672,657 Total Patients Enrolled
2 Trials studying Burns
40 Patients Enrolled for Burns
Wesley Thayer, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
19 Total Patients Enrolled
~6 spots leftby Dec 2024
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