Testing IP2 - for burn scar
Official title: Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
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
- Phase 2
- 2 groups
- Sites in Edmonton and Hamilton
- Recruiting
Interventions
- Medication
IP1 control cream (Vehicle base)
Without FS2
- Medication
IP2 - 0.5% w/w FS2
FS2 in pharmaceutical compounding base
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
University of Alberta, Division of Plastic Surgery
Edmonton, Alberta
- Recruiting
Centre for Burn Research - Hamilton Health Sciences
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +12 to 65 years of age (inclusive)
- +Have a BMI between 15 and 35 kg/m2 (inclusive)
- +Medically able and willing to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →/assent to study requirements
- +Male and female burn patients
- +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 clinically acceptable results in the safety laboratory tests as deemed by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +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
- −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
- −Medically unable to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to study requirements
- −Treatment siteTrial siteA hospital or clinic where a study is actually run.Read more →(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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →, based on the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s assessment
- −Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- −Subjects who had taken part in an interventionalInterventional studyA study where participants are given something to see what happens.Read more → 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 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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 with a history of abnormal keloid scarring
- −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
- −Pregnant, or attempting to become pregnant
- −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 who smoke more than 20 cigarettes a day
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive one or more of: IP1 controlControl groupThe group a new treatment is measured against.Read more → cream (Vehicle base) and IP2 - 0.5% w/w FS2.
Registry label: A: Skin Grafted wound · B: Donor Skin Graft Harvest wound
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 70 people.
The study is currently expected to finish around November 2026.
The main measurement is taken over: 90 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Scar condition of the skin grafted wound on Day 90 as assessed by VSS — measured over 90 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06807021 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About IP1 control cream (Vehicle base)Drug
Without FS2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About IP2 - 0.5% w/w FS2Drug
FS2 in pharmaceutical compounding base
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 90 days.
The study as a whole is currently expected to finish around 2026-11-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 70 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Edmonton, Alberta, Canada; Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.