Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 10, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Burn; Multiple Body Regions, Max. Second DegreeThird-Degree BurnBurn Degree Second
Interventions
DRUG

Nefopam

Nefopam HCl inhibits the proliferation and viability of human mesenchymal fibroblasts with elevated β-catenin expression without affecting normal fibroblasts. Nefopam HCl primarily targets cells in which β-catenin is above normal physiologic levels. This threshold effect makes Nefopam HCl a good prospective therapeutic agent by limiting its effect to abnormal mesenchymal cells.Nefopam HCl has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds of critical depth that produces HTS in normal human volunteers Phase 1 study. In the current study, it is proposed that the concentration of the cream will be 3% and the timing of application will be delayed until after re-epithelialization at about 21 days to maximize the antiproliferative effects of NEFOPAM during the fibrotic/proliferative phase of healing.

OTHER

Placebo (Vehicle)

Participants will receive vehicle with out the investigational product

Trial Locations (1)

T6G2B7

RECRUITING

University of Alberta Hospital, Edmonton

All Listed Sponsors
lead

University of Alberta

OTHER