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

Last updated: November 14, 2025
Sponsor: Birch BioMed Inc
Overall Status: Active - Recruiting

Phase

2/3

Condition

Scar Tissue

Hyponatremia

Skin Wounds

Treatment

IP2 - 0.5% w/w FS2

IP1 control cream (Vehicle base)

Clinical Study ID

NCT06807021
B04-23-01-T0058
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Medically able and willing to consent to study requirements

  2. Adult, male and female burn patients

  3. Ages 18 to 60 years of age

  4. Able to understand the study requirements and consent without a translator

  5. Have a BMI between 15 and 35 kg/m2 (inclusive)

  6. Have clinically acceptable results in the safety laboratory tests as deemed by theinvestigator

  7. Have full thickness burn injury that requires partial thickness skin graft (meshed)for any location other than the face and genitalia

  8. Meshed skin graft size is between 50 cm2 and 800 cm2

  9. Maximum skin graft expansion ratio is 1:1.5

  10. Able to apply the IPs as instructed, whether by the participants themselves or theiraccompanying caregivers

Exclusion

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) take more than 14 days after the skin graftsurgery to reach complete re-epithelization, based on the investigator's assessment

  4. Expected to be medically unstable for the duration of the study period and anadditional 1-month thereafter

  5. Pregnant, or attempting to become pregnant

  6. Subjects who had taken part in an interventional clinical trial within 3 monthsprior to admission to this trial or who are currently participating in a clinicaltrial, whether an investigational drug was used or not

  7. Subjects who had any clinical evidence of severe ongoing or prolonged depression ormental 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 morethan 14 drinks per week for men or more than 7 drinks per week for women

  10. Subjects who have a history of substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patientintervention)

  11. Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiringdialysis or hemodynamic instability requiring vasopressor therapy at the time ofinitiation 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 thetreatment sites

  13. Subjects with a history of abnormal keloid scarring

  14. Subjects with additional concurrent illnesses or conditions that may have interferedwith 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 heartfailure or diabetes mellitus) or any clinically significant medical condition orhistory of any condition which may impair wound healing

  15. Subjects with a skin disorder that is chronic or currently active and which theinvestigator considers will adversely affect the healing of acute wounds or willinvolve 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 sensitivities to any components of the IPs

  18. Any other diagnosis, condition, physical or geographical limitation with theparticipant

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: IP2 - 0.5% w/w FS2
Phase: 2/3
Study Start date:
December 01, 2025
Estimated Completion Date:
November 06, 2026

Study 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)

Connect with a study center

  • University of Alberta, Division of Plastic Surgery

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of Alberta, Division of Plastic Surgery

    Edmonton 5946768, Alberta 5883102 T6G 2B7
    Canada

    Active - Recruiting

  • Centre for Burn Research - Hamilton Health Sciences

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Centre for Burn Research - Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943 L8L 2X2
    Canada

    Active - Recruiting

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