FS2 cream applied after skin grafts to reduce burn scarring
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
This study will test whether applying an FS2 cream after skin-graft surgery reduces scarring in people with burn injuries.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Birch BioMed Inc Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT06807021 on ClinicalTrials.gov |
What this trial studies
Participants are randomized in a double-blind design for the first 90 days to receive either a control cream or a 0.5% FS2 cream applied to both the skin graft and donor sites, with assessments at baseline and follow-up visits. After Day 90 everyone enters a 90-day open-label period in which all participants use the FS2 cream. Scar outcomes are measured by standardized photography and validated scar scales (POSAS and VSS) at each visit. An interim analysis after about 36 participants complete Day 90 may continue the blinded design or convert the study to full open-label depending on results.
Who should consider this trial
Good fit: Adolescents and adults aged 12–65 with full-thickness burns requiring partial-thickness skin grafts of 50–800 cm2 who can consent and attend follow-up visits are the intended participants.
Not a fit: Patients with facial or genital burns (excluded locations), grafts outside the 50–800 cm2 range, or who cannot apply topical treatments or complete study visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, FS2 cream could reduce scar thickness and improve the appearance and comfort of both donor and graft sites after burn surgery.
How similar studies have performed: Topical anti-scar approaches such as silicone and steroid-based treatments have shown mixed results, and FS2 (kynurenic acid) is a novel topical candidate with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta and 1 other locations
- University of Alberta, Division of Plastic Surgery — Edmonton, Alberta, Canada (Recruiting)
- Centre for Burn Research - Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Adam Kuttenkeuler
- Email: akuttenkeuler@nutrasource.ca
- Phone: +1519-341-3367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.