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NCT Number: NCT06807021

Post-Operative Use of FS2 to Mitigate Scarring 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.

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Key information

Conditions

Burn Scar Burn Wound Burns Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta, Division of Plastic Surgery, Edmonton, Alberta, Canada

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About this study

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), [email protected] (Email)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically able and willing to consent/assent to study requirements
  • Male and female burn patients
  • 12 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

Exclusion criteria

  • 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)
  • A history of radiotherapy to the study scar area
  • Subjects who have known sensitivity to any components of the IPs
  • Any other diagnosis, condition, physical or geographical limitation with the participant

Treatment and study plan

IP1 control cream (Vehicle base)

Drug

Without FS2

IP2 - 0.5% w/w FS2

Drug

FS2 in pharmaceutical compounding base

Primary outcomes

  1. Scar condition of the skin grafted wound on Day 90 as assessed by VSS

    Time frame: 90 days

    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)

Secondary outcomes

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

    Time frame: 90 days

    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)

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

    Time frame: Day 28 and Day 60

    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)

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

    Time frame: Day 28 and Day 60

    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)

  4. Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS

    Time frame: Day 28, Day 60 and Day 90

    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)

  5. 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

    Time frame: Day 28, Day 60 and Day 90

    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)

  6. Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS

    Time frame: Day 28, Day 60 and Day 90

    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)

  7. 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

    Time frame: Day 28, Day 60 and Day 90

    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)

  8. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS

    Time frame: Day 120 and Day 180

    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

  9. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS

    Time frame: Day 120 and Day 180

    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

  10. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS

    Time frame: Day 120 and Day 180

    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

  11. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS

    Time frame: Day 120 and Day 180

    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

  12. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS

    Time frame: Day 120 and Day 180

    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

  13. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS

    Time frame: Day 120 and Day 180

    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

  14. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS

    Time frame: Day 120 and Day 180

    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

  15. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS

    Time frame: Day 120 and Day 180

    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

  16. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS

    Time frame: Day 120 and Day 180

    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

  17. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS

    Time frame: Day 120 and Day 180

    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

  18. Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS

    Time frame: Day 120 and Day 180

    To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: skin grafted wound (Study Arm 1)

  19. Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS

    Time frame: Day 120 and Day 180

    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)

  20. Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)

    Time frame: Day 28, Day 60 and Day 90

    To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on burn injury-related quality of life

  21. Quality of life on Day 120 and Day 180 as assessed by BSHS-B

    Time frame: Day 120 and Day 180

    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

  22. Quality of life on Day 120 and Day 180 as assessed by BSHS-B

    Time frame: Day 120 and Day 180

    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

Other outcomes

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

    Time frame: Day 28, Day 60 and Day 90

    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)

  2. Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs

    Time frame: Day 28, Day 60 and Day 90

    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)

  3. Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs

    Time frame: Day 28, Day 60 and Day 90

    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)

  4. Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs

    Time frame: Day 28, Day 60 and Day 90

    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)

  5. Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs

    Time frame: Day 120 and Day 180

    To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: skin grafted wound (Study Arm 1)

  6. Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs

    Time frame: Day 120 and Day 180

    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)

  7. Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs

    Time frame: Day 120 and Day 180

    To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: donor skin graft harvest site (Study Arm 2)

  8. Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs

    Time frame: Day 120 and Day 180

    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)

  9. To evaluate the Safety of FS2 Cream - Adverse events

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Report of Adverse Events

  10. To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  11. To evaluate the safety of FS2 cream - Hematocrit (%)

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  12. To evaluate the safety of FS2 cream - Red Blood Cell Count

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  13. To evaluate the safety of FS2 cream - Red Cell distribution Width

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  14. To evaluate the safety of FS2 cream - Mean corpuscular Volume

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  15. To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  16. To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  17. To evaluate the safety of FS2 cream - White Blood Cell Count and Differential

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  18. To evaluate the safety of FS2 cream - Platelet Count

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  19. To evaluate the safety of FS2 cream - Mean Platelet Volume

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory Parameters - Hematology Parameters (Complete blood count)

  20. To evaluate the safety of FS2 cream - AST

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety Laboratory parameters: Clinical Chemical Parameters

  21. To evaluate the safety of FS2 cream - ALT

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety laboratory parameters: Clinical chemistry parameters:

  22. To evaluate the safety of FS2 cream - GGT

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.

  23. To evaluate the safety of FS2 cream - Alkaline Phosphate

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety laboratory parameters: Clinical chemistry parameters

  24. To evaluate the safety of FS2 cream - Creatinine

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety laboratory parameters Clinical chemistry parameters.

  25. To evaluate the safety of FS2 cream - BUN

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.

  26. To evaluate the safety of FS2 cream - Bilirubin Total

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety laboratory parameters: Clinical chemistry parameters.

  27. To evaluate the safety of FS2 cream - Bilirubin Direct

    Time frame: Day 0, Day 28, Day 60, Day 90 and Day 180

    Safety laboratory parameters: Clinical chemistry parameter.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Kuttenkeuler

CONTACT

[email protected]

+1519-341-3367 ext. 113

Stephanie Recker

CONTACT

[email protected]

1-887-557-7722

Sponsors and collaborators

Lead sponsor

Birch BioMed Inc

Industry

Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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