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Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.

NCT04186273 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-17

No results posted yet for this study

Summary

The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Results of recent peer-reviewed, pre-clinical evidence warrant further investigation to validate therapeutic scar preventive efficacy of topically administered/delivered FS2. There are no known safety concerns with current product formulations. Recent Phase I clinical safety and tolerability data further support continuation of the research proposed in this study.

Conditions

  • Scar
  • Cicatrix
  • Hypertrophic Scar
  • Skin Graft Scar
  • Skin Graft Complications
  • Donor Site Complication
  • Keloid

Interventions

DRUG

Fibrosis-Inhibiting-Compound-FS2

There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.

OTHER

Vehicle moisture balancing base

Vehicle base without FS2.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Anthony Papp, MD, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2021-02-01
Completion
2021-03-01

Countries

  • Canada

Study Locations

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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 NCT04186273 on ClinicalTrials.gov