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Antifibrotic
Donor Site Wound, FS2 0.5 for Scar (FS2 Trial)
Phase 2
Waitlist Available
Led By Anthony Papp, MD, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 hours; 0-9 months
Awards & highlights
FS2 Trial Summary
This trial will study the safety and effectiveness of a new ointment for managing scars after surgery. The ointment contains an antifibrogenic compound that has shown promise in preliminary studies. There are no known safety concerns with the ointment.
Eligible Conditions
- Scar
- Scarring
- Hypertrophic Scar
- Skin Graft Scar
- Skin Graft Complications
- Donor Site Complication
- Keloid
FS2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-2 hours; 0-9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 hours; 0-9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient and Observer Scar Assessment Scale (POSAS)
Vancouver Scar Scale (VSS)
Secondary outcome measures
Adverse Events
Clinical Chemistry Results
FS2 Pharmacokinetic blood analysis data
+11 moreFS2 Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Skin Graft Wound, FS2 0.5Experimental Treatment1 Intervention
A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site.
Group II: Skin Graft Wound, FS2 0.25Experimental Treatment1 Intervention
A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site.
Group III: Donor Site Wound, FS2 0.5Experimental Treatment1 Intervention
A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested)
Group IV: Donor Site Wound, FS2 0.25Experimental Treatment1 Intervention
A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested).
Group V: Donor Site Wound, VehiclePlacebo Group1 Intervention
A vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested).
Group VI: Skin Graft Wound, VehiclePlacebo Group1 Intervention
A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,068 Total Patients Enrolled
Anthony Papp, MD, PhDPrincipal InvestigatorUniversity of British Columbia
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