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FS2 for Scarring from Burns
Hamilton, Canada
Phase 2 & 3
Waitlist Available
Research Sponsored by Birch BioMed Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18 to 60 years of age
BMI between 15 and 35 kg/m2
Must not have
Medically unable to consent to study requirements
History of radiotherapy to the study scar area
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 28, day 60, day 90 and day 180
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate how a substance called kynurenic acid (FS2) affects scar formation in burn injury patients undergoing skin graft surgery. A cream containing FS2 will be applied to both
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Who is the study for?
Adult burn patients aged 18-60 with a BMI of 15-35 kg/m2 who need skin grafts for burns, excluding the face and genitalia. Participants must be able to apply treatment creams themselves or with help, not smoke heavily, avoid heavy drinking or substance abuse recently, and have no history of keloid scarring or sensitivities to cream ingredients.Check my eligibility
What is being tested?
The trial is testing a cream containing kynurenic acid (FS2) on scar formation after skin graft surgery in burn patients. The study compares FS2 cream's safety and effectiveness against a control cream when applied to both the grafted area and donor site post-healing.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the components of FS2 or the control cream. These could involve local skin reactions such as redness, itching, swelling at the application sites.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
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My BMI is between 15 and 35.
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I need a skin graft for a burn, not on my face or genital area.
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My skin graft size is between 50 cm2 and 800 cm2.
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My skin graft will not be stretched more than 1.5 times its original size.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not able to understand and agree to the study's requirements due to my health condition.
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I have had radiation therapy on the scar that is being studied.
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My treatment is for areas on my face or genitals.
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I have not had severe depression or mental illness in the past year.
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I do not have severe lung damage, kidney failure needing dialysis, or unstable blood pressure as I start the study treatment.
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I have scars near where they plan to treat my condition.
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I have skin conditions that could affect healing.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 28, day 60, day 90 and day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 28, day 60, day 90 and day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
Secondary study objectives
Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
+12 moreOther study objectives
Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
+24 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Skin Grafted woundExperimental Treatment2 Interventions
The wound site (injury)
Group II: Donor Skin Graft Harvest woundExperimental Treatment2 Interventions
A Surgical wound
Find a Location
Closest Location:Centre for Burn Research - Hamilton Health Sciences· Hamilton, Canada
Who is running the clinical trial?
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
39 Previous Clinical Trials
2,317 Total Patients Enrolled
Birch BioMed IncLead Sponsor
Carlos Camozzi, MD, PHDStudy DirectorBirchBioMed Inc.