NCT06362226

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-04-28
• Primary completion: 2026-11-01
• Completion: 2027-01-01
• First posted: 2024-04-12
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study