Clinical trial NCT06807021: Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Burn Scar
Burn Wound
Keywords: Scar
Burn
skin graft
Kynurenic acid
FS2
Skin grafted wound
Donor Wound
Lead sponsor: Birch BioMed Inc
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2025-02-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, vehicle-controlled, Randomized, Double-blinded
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: For the first 90 days of the study, neither the patient nor the investigator will know which cream is being used: either the control cream (IP1) or the treatment cream (IP2), which contains 0.5% FS2. The assigned study product will be applied to the donor site and the skin graft site. After the first 90 days, all patients will use the FS2 cream for another 90 days in an open-label period where everyone knows they are receiving FS2.

The graft and donor sites will be photographed and assessed (POSAS and VSS), scored and recorded at the initial visit and again at every assessment visit thereafter.

An interim analysis will take place when about half of the participants (36 people) have finished their Day 90 visit. Based on the results, the study may continue as planned with the two-treatment, blinded design, or it may switch to an open-label format where all patients (those already in the study or newly enrolled) will use the FS2 cream.

Eligibility criteria: Inclusion Criteria:

1. Medically able and willing to consent to study requirements
2. Adult, male and female burn patients
3. Ages 18 to 60 years of age
4. Able to understand the study requirements and consent without a translator
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 requires partial thickness skin graft (meshed) for any location other than the face and genitalia
8. Meshed skin graft size is between 50 cm2 and 800 cm2
9. 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) take more than 14 days after the skin graft surgery to reach complete re-epithelization, 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 in 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 sensitivities to any components of the IPs
18. Any other diagnosis, condition, physical or geographical limitation with the participant

Primary outcomes:
measure: Scar condition of the skin grafted wound on Day 90 as assessed by VSS
timeFrame: 90 days
Secondary outcomes:
measure: Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
timeFrame: 90 days
measure: Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS
timeFrame: Day 28 and Day 60
measure: Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS
timeFrame: Day 28 and Day 60
measure: Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
timeFrame: Day 28, Day 60 and Day 90
measure: Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
timeFrame: Day 28, Day 60 and Day 90
measure: Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
timeFrame: Day 28, Day 60 and Day 90
measure: Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
timeFrame: Day 28, Day 60 and Day 90
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
timeFrame: Day 120 and Day 180
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
timeFrame: Day 120 and Day 180
measure: Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
timeFrame: Day 120 and Day 180
measure: Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
timeFrame: Day 120 and Day 180
measure: Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)
timeFrame: Day 28, Day 60 and Day 90
measure: Quality of life on Day 120 and Day 180 as assessed by BSHS-B
timeFrame: Day 120 and Day 180
measure: Quality of life on Day 120 and Day 180 as assessed by BSHS-B
timeFrame: Day 120 and Day 180
Other outcomes:
measure: Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
timeFrame: Day 28, Day 60 and Day 90
measure: Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
timeFrame: Day 28, Day 60 and Day 90
measure: Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
timeFrame: Day 28, Day 60 and Day 90
measure: Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
timeFrame: Day 28, Day 60 and Day 90
measure: Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
timeFrame: Day 120 and Day 180
measure: Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
timeFrame: Day 120 and Day 180
measure: Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
timeFrame: Day 120 and Day 180
measure: Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
timeFrame: Day 120 and Day 180
measure: To evaluate the Safety of FS2 Cream - Adverse events
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Hematocrit (%)
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Red Blood Cell Count
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Red Cell distribution Width
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Mean corpuscular Volume
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - White Blood Cell Count and Differential
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Platelet Count
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Mean Platelet Volume
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - AST
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - ALT
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - GGT
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Alkaline Phosphate
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Creatinine
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - BUN
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Bilirubin Total
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
measure: To evaluate the safety of FS2 cream - Bilirubin Direct
timeFrame: Day 0, Day 28, Day 60, Day 90 and Day 180
Locations:
city: Hamilton
country: Canada
facility: Centre for Burn Research - Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: BirchBioMed Inc.
name: Carlos Camozzi, MD, PHD
role: STUDY_DIRECTOR
References: