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RECRUITING
NCT06807021
PHASE2/PHASE3

Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients

Sponsor: Birch BioMed Inc

View on ClinicalTrials.gov

Summary

The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.

Official title: Post-operative Topical Administration of Fibrosis Inhibiting Compound FS2 in a Double- Blind, Randomized, Vehicle-controlled Study Evaluating the Safety and Mitigation of Cutaneous Scarring in Skin Graft and Donor Sites in Burn Patients

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-12-01

Completion Date

2026-11-06

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DRUG

IP1 control cream (Vehicle base)

Without FS2

DRUG

IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base

Locations (2)

University of Alberta, Division of Plastic Surgery

Edmonton, Alberta, Canada

Centre for Burn Research - Hamilton Health Sciences

Hamilton, Ontario, Canada