RecruitingPhase 2Phase 3NCT06807021
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
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
Sponsor
Birch BioMed Inc
Enrollment
70 participants
Start Date
May 15, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 12 YearsMax Age: 65 Years
Inclusion Criteria10
- 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 Criteria18
- 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
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Interventions
DRUGIP1 control cream (Vehicle base)
Without FS2
DRUGIP2 - 0.5% w/w FS2
FS2 in pharmaceutical compounding base
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06807021
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