BridgeMD
New treatment option for Burn Scar
Official title Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
ClinicalTrials.gov ID: NCT06807021
What this study is testing
What is IP1 control cream (Vehicle base)?
IP1 control cream (Vehicle base) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for burn scar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- 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)...
- Have a BMI between 15 and 35 kg/m2 (inclusive)
You likely can't join if
- 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...
- Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant, or attempting to become pregnant
- people who had taken part in an treatment clinical trial within 3 months prior to admission to this trial or who are currently participating in a...
See the full eligibility 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...
- 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
- 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
- people who had taken part in an treatment 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
- people who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
- people who smoke more than 20 cigarettes a day
- people 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
- people 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)
- people 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
- people 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
- people with a history of abnormal keloid scarring
- people 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...
- people 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...
- A history of radiotherapy to the study scar area
- people who have known sensitivity to any components of the IPs
- Any other diagnosis, condition, physical or geographical limitation with the participant
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.