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

NCT06807021 | Recruiting Phase 2

• 1 other identifier: B04-23-01-T0058
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Burn Scar; Burn Wound

Keywords

Scar; Burn; skin graft; Kynurenic acid; FS2; Skin grafted wound; Donor Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS

  90 days

• Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS

  Day 28 and Day 60

• Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS

  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

  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

  Day 28, Day 60 and Day 90

Other Outcomes (27)

• Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs

  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

  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

  Day 28, Day 60 and Day 90

Study Arms (2)

Skin Grafted wound

EXPERIMENTAL

The wound site (injury)

Drug: IP1 control cream (Vehicle base); Drug: IP2 - 0.5% w/w FS2

Donor Skin Graft Harvest wound

EXPERIMENTAL

A Surgical wound

Drug: IP1 control cream (Vehicle base); Drug: IP2 - 0.5% w/w FS2

Interventions

IP1 control cream (Vehicle base) DRUG

Without FS2

Donor Skin Graft Harvest wound; Skin Grafted wound

IP2 - 0.5% w/w FS2 DRUG

FS2 in pharmaceutical compounding base

Donor Skin Graft Harvest wound; Skin Grafted wound

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically able and willing to consent/assent to study requirements
• Male and female burn patients
• to 65 years of age (inclusive)
• 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.
• Have a BMI between 15 and 35 kg/m2 (inclusive)
• Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
• Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
• Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
• If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
• Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

You may not qualify if:

• Medically unable to consent to study requirements
• Treatment site(s) (skin graft site) located on the face and genitalia
• 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
• Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
• Pregnant, or attempting to become pregnant
• 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
• Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
• Subjects who smoke more than 20 cigarettes a day
• 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
• 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)
• 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
• 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
• Subjects with a history of abnormal keloid scarring
• 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
• 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)

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator
• Birch BioMed Inc: lead

Study Sites (2)

University of Alberta, Division of Plastic Surgery

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Centre for Burn Research - Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Burns; Cicatrix

Interventions

I-kappa B Kinase

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Carlos Camozzi, MD, PHD

  BirchBioMed Inc.

  STUDY DIRECTOR

Central Study Contacts

Adam Kuttenkeuler

CONTACT

+1519-341-3367; akuttenkeuler@nutrasource.ca

Stephanie Recker

CONTACT

1-887-557-7722; srecker@nutrasource.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel, vehicle-controlled, Randomized, Double-blinded

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 4, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)