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

Overview

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.

Oversight - Human Subjects Protection Review section continued:

Site #02 (Edmonton) Approval Number: Pro00151882 Board Name: HREB - Biomedical Panel Board Affiliation: HREB - University of Alberta Board Contact Information: 780-492-8320 (Phone), vnadeau@ualberta.ca (Email)

Interventions

• Drug IP1 control cream (Vehicle base)
  Without FS2
• Drug IP2 - 0.5% w/w FS2
  FS2 in pharmaceutical compounding base

Primary outcome measures

• Scar condition of the skin grafted wound on Day 90 as assessed by VSS [Time frame: 90 days]

Secondary outcome measures (12)

• Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS [Time frame: 90 days]
• Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS [Time frame: Day 28 and Day 60]
• Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS [Time frame: Day 28 and Day 60]
• Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS [Time frame: Day 28, Day 60 and Day 90]
• 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 [Time frame: Day 28, Day 60 and Day 90]
• Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS [Time frame: Day 28, Day 60 and Day 90]
• 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 [Time frame: Day 28, Day 60 and Day 90]
• Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS [Time frame: Day 120 and Day 180]
• Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS [Time frame: Day 120 and Day 180]
• Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS [Time frame: Day 120 and Day 180]
• Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS [Time frame: Day 120 and Day 180]
• Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS [Time frame: Day 120 and Day 180]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

Canada · 2 centers

• University of Alberta, Division of Plastic Surgery — Edmonton
• Centre for Burn Research - Hamilton Health Sciences — Hamilton

Identifiers

NCT: NCT06807021 · B04-23-01-T0058

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗