Recruiting
Phase 2
Phase 3

FS2

Sponsor:

Birch BioMed Inc

Code:

NCT06807021

Conditions

Burn Scar

Burn Wound

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

Interventions

IP1 control cream (Vehicle base)

IP2 - 0.5% w/w FS2

Study Details

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

Study ID

NCT06807021

Start date

May 15, 2026

Status verified date

Apr, 2026

Completion date

Nov 6, 2026

Anticipated

Primary completion date

Oct 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Skin Grafted wound

The wound site (injury)

experimental: Donor Skin Graft Harvest wound

A Surgical wound

Interventions

IP1 control cream (Vehicle base)

Without FS2

IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base

Primary outcome measure

  • Scar condition of the skin grafted wound on Day 90 as assessed by VSS [ Time Frame: 90 days ]

Central Contacts and Locations

Locations

University of Alberta, Division of Plastic Surgery

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Principal Investigator:

Alex Morzycki, MD

Centre for Burn Research - Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Principal Investigator:

Marc Jeschke, PHD

More Information

Sponsor

Birch BioMed Inc

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Birch BioMed Inc on 2026-05-04.