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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Scar; Burn Wound
• Intervention / Treatment: Drug: IP1 control cream (Vehicle base); Drug: IP2 - 0.5% w/w FS2

Detailed Description

For the first 90 days of the study, neither the patient nor the investigator will know which cream is being used: either the control cream (IP1) or the treatment cream (IP2), which contains 0.5% FS2. The assigned study product will be applied to the donor site and the skin graft site. After the first 90 days, all patients will use the FS2 cream for another 90 days in an open-label period where everyone knows they are receiving FS2.

The graft and donor sites will be photographed and assessed (POSAS and VSS), scored and recorded at the initial visit and again at every assessment visit thereafter.

An interim analysis will take place when about half of the participants (36 people) have finished their Day 90 visit. Based on the results, the study may continue as planned with the two-treatment, blinded design, or it may switch to an open-label format where all patients (those already in the study or newly enrolled) will use the FS2 cream.

Oversight - Human Subjects Protection Review section continued:

Site #02 (Edmonton) Approval Number: Pro00151882 Board Name: HREB - Biomedical Panel Board Affiliation: HREB - University of Alberta Board Contact Information: 780-492-8320 (Phone), vnadeau@ualberta.ca (Email)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Stephanie Recker; Phone Number: 1-887-557-7722; Email: srecker@nutrasource.ca
• Study Contact Backup: Name: Adam Kuttenkeuler; Phone Number: 113 +1519-341-3367; Email: akuttenkeuler@nutrasource.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta, Division of Plastic Surgery
      • Contact: Sharada Manchikanti, MD; Phone Number: 780-407-5203; Email: Sharada.Manchikanti@albertahealthservices.ca
      • Principal Investigator: Alex Morzycki, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Centre for Burn Research - Hamilton Health Sciences
      • Contact: Esohe Ogbomo, BSc, MPH; Phone Number: 40790 905-521-2100; Email: Esohe.Ogbomo@TAARI.CA
      • Contact: Hannah Hamm; Phone Number: 40790 905-521-2100; Email: Hannah.Hamm@TAARI.CA
      • Principal Investigator: Marc Jeschke, PHD
      • Sub-Investigator: Stephanie Chadwick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Medically able and willing to consent/assent to study requirements
2. Male and female burn patients
3. 12 to 65 years of age (inclusive)
4. Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized representative (LAR) is willing and able to agree to the requirements and restrictions of the study, be willing to give voluntary informed consent (or assent, if capable), be able to understand and read the questionnaires, carry out all study-related procedures, and communicate effectively with the study staff.
5. Have a BMI between 15 and 35 kg/m2 (inclusive)
6. Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
7. Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
8. Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
9. If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
10. Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

Exclusion Criteria:

1. Medically unable to consent to study requirements
2. Treatment site(s) (skin graft site) located on the face and genitalia
3. Treatment site(s) (skin graft site and skin donor site) that has not reached complete re-epithelization at baseline, based on the investigator's assessment
4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
5. Pregnant, or attempting to become pregnant
6. Subjects who had taken part in an interventional clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not
7. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
8. Subjects who smoke more than 20 cigarettes a day
9. Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
10. Subjects who have a history of substance abuse within the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
11. Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
12. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
13. Subjects with a history of abnormal keloid scarring
14. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled HIV infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing
15. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
16. A history of radiotherapy to the study scar area
17. Subjects who have known sensitivity to any components of the IPs
18. Any other diagnosis, condition, physical or geographical limitation with the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin Grafted wound; The wound site (injury)	Drug: IP1 control cream (Vehicle base); Without FS2; Drug: IP2 - 0.5% w/w FS2; FS2 in pharmaceutical compounding base
Experimental: Donor Skin Graft Harvest wound; A Surgical wound	Drug: IP1 control cream (Vehicle base); Without FS2; Drug: IP2 - 0.5% w/w FS2; FS2 in pharmaceutical compounding base

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar condition of the skin grafted wound on Day 90 as assessed by VSS	To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS	To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)	90 days
Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS	To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: skin grafted wound (Study Arm 1)	Day 28 and Day 60
Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS	To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: donor skin graft harvest site (Study Arm 2)	Day 28 and Day 60
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS	To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by the Observer component of Patient and Observer Scar Assessment Scale (POSAS) at skin grafted wound (Study Arm 1)	Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS	To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by (POSAS) at: donor skin graft harvest site (Study Arm 2)	Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS	To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: skin grafted wound (Study Arm 1)	Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS	To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)	Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS	Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS	Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: skin grafted wound (Study Arm 1) -POSAS	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS	Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS	To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS	To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS	Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS	To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS	To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS	Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS	To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: skin grafted wound (Study Arm 1)	Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS	To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)	Day 120 and Day 180
Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)	To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on burn injury-related quality of life	Day 28, Day 60 and Day 90
Quality of life on Day 120 and Day 180 as assessed by BSHS-B	Quality of life on Day 120 and Day 180 as assessed by BSHS-B To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on burn injury-related quality of life in those randomized to control for the first 90 days of study	Day 120 and Day 180
Quality of life on Day 120 and Day 180 as assessed by BSHS-B	To evaluate the effect of 120- and 180-day FS2 cream use on burn injury-related quality of life in those randomized to FS2 cream for the first 90 days of study Quality of life on Day 120 and Day 180 as assessed by BSHS-B	Day 120 and Day 180

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs	To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)	Day 28, Day 60 and Day 90
Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs	To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)	Day 28, Day 60 and Day 90
Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs	To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)	Day 28, Day 60 and Day 90
Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs	To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)	Day 28, Day 60 and Day 90
Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs	To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: skin grafted wound (Study Arm 1)	Day 120 and Day 180
Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: skin grafted wound (Study Arm 1)	Day 120 and Day 180
Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs	To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: donor skin graft harvest site (Study Arm 2)	Day 120 and Day 180
Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs	To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: donor skin graft harvest site (Study Arm 2)	Day 120 and Day 180
To evaluate the Safety of FS2 Cream - Adverse events	Report of Adverse Events	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Hematocrit (%)	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Blood Cell Count	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Cell distribution Width	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Volume	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - White Blood Cell Count and Differential	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Platelet Count	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean Platelet Volume	Safety Laboratory Parameters - Hematology Parameters (Complete blood count)	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - AST	Safety Laboratory parameters: Clinical Chemical Parameters	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - ALT	Safety laboratory parameters: Clinical chemistry parameters:	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - GGT	To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Alkaline Phosphate	Safety laboratory parameters: Clinical chemistry parameters	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Creatinine	Safety laboratory parameters Clinical chemistry parameters.	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - BUN	To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Total	Safety laboratory parameters: Clinical chemistry parameters.	Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Direct	Safety laboratory parameters: Clinical chemistry parameter.	Day 0, Day 28, Day 60, Day 90 and Day 180

Collaborators and Investigators

• Sponsor: Birch BioMed Inc
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Study Director: Carlos Camozzi, MD, PHD, BirchBioMed Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 6, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Scar; Burn; skin graft; Kynurenic acid; FS2; Skin grafted wound; Donor Wound
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Fibrosis; Pathological Conditions, Signs and Symptoms; Burns; Cicatrix; Amino Acids, Peptides, and Proteins; Proteins; Enzymes; Enzymes and Coenzymes; Transferases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Intracellular Signaling Peptides and Proteins; I-kappa B Kinase
• Other Study ID Numbers: B04-23-01-T0058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No