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Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management

NCT06362226 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.

Conditions

  • Periorbital Burns

Interventions

DRUG

Steroid/Antibiotic (Maxitrol)

Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks

DRUG

5-FU/Kenalog

Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Nikisha Richards, MD, FACS · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-11-30
Completion
2027-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362226 on ClinicalTrials.gov