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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
IP1 control cream (Vehicle base)
DrugWithout FS2
IP2 - 0.5% w/w FS2
DrugFS2 in pharmaceutical compounding base
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Skin Grafted woundExperimental treatment 2 interventions
Group B: Donor Skin Graft Harvest woundExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)
Time frame
90 daysSecondary outcomes
1
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)
Time frame
90 days2
Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS
To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: skin grafted wound (Study Arm 1)
Time frame
Day 28 and Day 603
Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS
To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: donor skin graft harvest site (Study Arm 2)
Time frame
Day 28 and Day 604
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by the Observer component of Patient and Observer Scar Assessment Scale (POSAS) at skin grafted wound (Study Arm 1)
Time frame
Day 28, Day 60 and Day 90Other outcomes
1
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Time frame
Day 28, Day 60 and Day 902
Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Time frame
Day 28, Day 60 and Day 903
Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Time frame
Day 28, Day 60 and Day 904
Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Time frame
Day 28, Day 60 and Day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Birch BioMed Inc
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov