Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorBirch BioMed Inc
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- IP1 control cream (Vehicle base)
- IP2 - 0.5% w/w FS2
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Birch BioMed Inc
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov