Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients (NCT06807021) | Clinical Trial Compass
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Canada70 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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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)
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
What they're measuring
1
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
✕. 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