← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

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

Neurotoxicity

Graft loss

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,175 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients welcome in this clinical experiment?

"This research is open to individuals that are aged 50 and above, provided they do not exceed the age of 75."

Answered by AI

How many participants are actively enrolled in this research project?

"Affirmative. Clinicaltrials.gov indicates that, as of September 7th 2023, this clinical trial is still actively recruiting participants. Since it's inception on August 1st 2023, the study has set out to gather data from 18 people at a single location."

Answered by AI

Are there any possibilities for enrollment in this trial?

"Clinicaltrials.gov indicates that recruitment for this scientific endeavour began on August 1st, 2023 and the most recent update was made September 7th of the same year."

Answered by AI

What can be expected in terms of potential side effects when using Tacrolimus Ointment 0.03% with hydrocolloid dressing?

"Due to limited evidence of safety and efficacy, the team at Power assigned Tacrolimus Ointment 0.03% with hydrocolloid dressing a score of 1 on their scale from 1 to 3."

Answered by AI

Who is best suited to participate in this medical experiment?

"This clinical trial is presently recruiting 18 participants aged 50 to 75 who have experienced thermal burns on their hands. To qualify, individuals must provide signed Informed Consent, display a willingness to comply with all study procedures and be present for the duration of the research; additionally, women of child-bearing potential are required to pass a urine pregnancy test upon enrollment and burns located across other body parts should not exceed 5% Total Body Surface Area (TBSA). Furthermore, treatment should commence within 24-48 hours post injury."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Wesley Thayer 2023. "Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856994.