ScarPhase 2FS2NCT04186273
Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.
A Phase 2 study testing Fibrosis-Inhibiting-Compound-FS2 in people with Scar and Cicatrix, run by University of British Columbia at 1 site in Canada.
Trial summary
The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar, Cicatrix, Hypertrophic Scar
- What is being tested?
- Fibrosis-Inhibiting-Compound-FS2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2019to 1 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically able to consent to study requirements
- Adult, male and female trauma patients
- Ages 18 to 65 years of age
- Fluent in English (able to consent without a translator)
- Isolated skin wound of 3% Total Body Surface Area
- Participant requires partial thickness skin graft (meshed/non-meshed), face and genitalia excluded.
- Grafted skin is between 100 cm2 and 600 cm2
- Maximum skin graft expansion ratio is 1:1.5
Who cannot join
- Medically unable to consent to study requirements
- Require an English translator to lawfully consent to the study and its requirements
- Treatment sights (skin graft sights) located on the face and genitalia
- Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant, or attempting to become pregnant
- Known immunosuppression or immunosuppressive illness
Show all 11Show fewer
- Subjects who had taken part in a 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
- Subjects who smoke more than 20 cigarettes a day
- Subjects who demonstrated evidence of drug abuse
- Any other diagnosis, condition, physical or geographical limitation with the participant that may render, or increases the likelihood of rendering, him/her unable to complete the entire study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
VGH Burn Unit
Vancouver, British Columbia, V5Z 1M9
Tesnim Sairi, 604-875-4095, clinicaltrials@birchbiomed.com
About this study
Official title: Post-operative Topical Administration of Fibrosis Inhibiting Compound FS2 in a Double-blind, Randomized, Vehicle-controlled Study Evaluating the Safety and Prevention of Cutaneous Scarring in Skin Grafts and Donor Sites.
The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Results of recent peer-reviewed, pre-clinical evidence warrant further investigation to validate therapeutic scar preventive efficacy of topically administered/delivered FS2. There are no known safety concerns with current product formulations. Recent Phase I clinical safety and tolerability data further support continuation of the research proposed in this study.
Read the detailed description
Study Arms (Investigational Conditions):
Total of 6, categorized by type of wound and treatment allocation.
Description of Study Arms:
The quality of tissue repair and scarring will be evaluated in two different, bisected post-surgical sites on the same Participant. Each wound site represents a Study Arm. Each wound site will receive two treatments, one of which is always a vehicle. In total the two wound types provide a total of 6 Study Arms for statistical analysis.
Arm 1 / Wound Type 1 (skin grafted wounds: 3-treatment groups): The wound site (injury) that requires skin grafting surgery to remove normal, uninjured skin from the same Participant to cover and repair a deep wound (a "skin graft").
Arm 2 / Wound Type (donor skin graft harvest site; 3-treatment groups): A surgical wound where a piece of normal skin is removed at uniform depth using a dermatome to harvest a skin graft ("skin graft harvest site").
The bisected wound site is randomly assigned either a control or FS2 cream treatment.
Treatment Groups: Each wound site will be used to investigate and compare three different treatments. Participants will apply the investigated treatments ("IP") as directed to allocated bisected sections of the skin grafted wound and donor wound site for 90 days. Follow-on assessments will be conducted with additional study visits on Days 180 and 270 (study endpoint).
There are four (4) differently labelled products as follows:
Treatment-1 (IP1) A single, daily application of a moisturizing cream-base.
Treatment-2 (IP2) A single, daily application of a moisturizing cream-base with FS2 (0.50% w/w).
Treatment-3 (IP3) A single, daily application of a moisturizing cream-base with FS2 (0.25% w/w). IP3 will have two different product labels to conceal the identity of the vehicle.
Control-cream (IP1), and treatments IP2 and IP3 each containing 0.50%w/w or 0.25%w/w FS2 respectively, will be topically applied to designated treatment sites once per day for a period of 90 days. Investigator and participant will be blinded from both identity of treatment product and randomized location. Each participant will be provided a different cream for each bisected-site for a total of four (4) differently labelled creams; two for the donor site, and two for the skin grafted site. Participants will discuss and be informed/reminded at each visit about study design, responsibilities, possible adverse events, proper daily wound care and cream application methods.
- Conditions
- Scar, Cicatrix, Hypertrophic Scar, Skin Graft Scar, Skin Graft Complications, Donor Site Complication
- Being tested
- Fibrosis-Inhibiting-Compound-FS2, Vehicle moisture balancing base
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrosis-Inhibiting-Compound-FS2Drug
Also called FS2
There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
Vehicle moisture balancing baseOther
Also called Vehicle
Vehicle base without FS2.
| Study group | Role | What they receive |
|---|---|---|
| Donor Site Wound, Vehicle | Sham comparator | A vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested). Receives: Other: Vehicle moisture balancing base |
| Donor Site Wound, FS2 0.25 | Experimental | A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested). Receives: Drug: Fibrosis-Inhibiting-Compound-FS2 |
| Donor Site Wound, FS2 0.5 | Experimental | A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested) Receives: Drug: Fibrosis-Inhibiting-Compound-FS2 |
| Skin Graft Wound, Vehicle | Sham comparator | A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site. Receives: Other: Vehicle moisture balancing base |
| Skin Graft Wound, FS2 0.25 | Experimental | A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site. Receives: Drug: Fibrosis-Inhibiting-Compound-FS2 |
| Skin Graft Wound, FS2 0.5 | Experimental | A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site. Receives: Drug: Fibrosis-Inhibiting-Compound-FS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
Differences in clinical scale scoring of healing, complications and scar severity using Vancouver Scar Scale. Investigator assessment of target scar or keloid using the Vancouver Scar Scale (VSS). Scale parameters include: Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), and Height (0-3). Scale measurements include: minimum score of 0 = normal to a maximum score of 2, 3 or 5 depending on the parameter measured.
Measured: 0-9 months
Patient and Observer Scar Assessment Scale (POSAS)
Differences in clinical scale scoring of healing, complications and scar severity using Patient and Observer Scar Assessment Scale (POSAS). Investigator assessment of target scar or keloid using the Patient and Observer Scar Assessment Scale (POSAS). Scale parameters include: Vascularity, Pigmentation, Thickness, Relief, Pliability, and Surface Area. Scale measurements include: minimum score of 1 = normal skin to a maximum score of 10 = worst scar imaginable.
Measured: 0-9 months
Secondary outcomes (15)
Adverse Events
To evaluate and compare Treatment safety by the proportion of adverse events in each treatment arm.
Measured: 0-9 months
Vital Signs - systolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal systolic blood pressures in each participant.
Measured: 0-9 months
Vital Signs - diastolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal diastolic blood pressures in participant.
Measured: 0-9 months
Vital Signs - Heart Rate
To evaluate and compare Treatment safety by the proportion of abnormal heart rates in each participant.
Measured: 0-9 months
Vital Signs - Respiratory Rate
To evaluate and compare Treatment safety by the proportion of abnormal respiratory rates in each participant.
Measured: 0-9 months
Vital Signs - Oral Temperature
To evaluate and compare Treatment safety by the proportion of abnormal temperatures in each participant.
Measured: 0-9 months
Physical Exam Findings
To evaluate and compare Treatment safety by the proportion of abnormal physical exam findings in each participant.
Measured: 0-9 months
Clinical Chemistry Results
To evaluate and compare Treatment safety by the proportion of abnormal clinical chemistry results in each participant.
Measured: 0-9 months
Hematology Results
To evaluate and compare Treatment safety by the proportion of abnormal hematology results for each participant.
Measured: 0-9 months
Urine Analysis Results
To evaluate and compare Treatment safety by the proportion of abnormal urine analysis results for each participant.
Measured: 0-9 months
FS2 Pharmacokinetic urine analysis data
To obtain, evaluate and compare total urine drug concentrations for each participant and compare clearance normalized by estimated volume of distribution (Vd).
Measured: 0-2 hours; 0-9 months
FS2 Pharmacokinetic blood analysis data
To obtain, evaluate and compare total blood drug concentrations for each participant and compare clearance normalized by estimated volume of distribution (Vd).
Measured: 0-2 hours; 0-9 months
Pain Management
Pain Visual Analog Scale longitudinal comparison of subjective changes for each participant.
Pain, Visual analog scale (score 0-none to 10-worse)
Measured: 0-9months
Histology (Tissue Biopsies)
Evaluate and compare pathological assessments of punch biopsies obtained from each treatment site and compare intra site subjective findings (qualitative) for each.
Measured: 3 months and 9 months
Histology (Tissue Biopsies)
Evaluate and compare intra site scar elevation index ratios (comparative ratio of normal skin dimensions (e.g. thickness) to those of an adjacent scar). Assessment requires histology sections of punch biopsies obtained from each treatment site and further substantiates Outcome 16 above.
Measured: 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Dec 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- QUADRUPLE-BLINDED, RANDOMIZED, VEHICLE-CONTROLLED STUDY INTRA-SUBJECT CONTROLS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Papp, University of British Columbia
- Investigators
- Anthony Papp, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186273
- Sponsor's protocol ID
- H16-02491
- Acronym
- FS2
- Status last verified
- Dec 2019
- First submitted
- 15 Nov 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to disseminate individual participant data at this time, beyond what will be accessible through publication.
Publications
Papp A, Hartwell R, Evans M, Ghahary A. The Safety and Tolerability of Topically Delivered Kynurenic Acid in Humans. A Phase 1 Randomized Double-Blind Clinical Trial. J Pharm Sci. 2018 Jun;107(6):1572-1576. doi: 10.1016/j.xphs.2018.01.023. Epub 2018 Feb 6.
PubMed 29421218
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Topical Administration of Fibrosis Inhibiting Compound FS2 in a Double-blind, Randomized, Vehicle-controlled Study Evaluating the Safety and Prevention of Cutaneous Scarring in Skin Grafts and Donor Sites.
- ClinicalTrials.gov ID
- NCT04186273
- Acronym / sponsor ID
- FS2 / H16-02491
- Conditions
- Scar, Cicatrix, Hypertrophic Scar, Skin Graft Scar, Skin Graft Complications, Donor Site Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Results of recent peer-reviewed, pre-clinical evidence warrant further investigation to validate therapeutic scar preventive efficacy of topically administered/delivered FS2. There are no known safety concerns with current product formulations. Recent Phase I clinical safety and tolerability data further support continuation of the research proposed in this study.
Detailed description
Study Arms (Investigational Conditions):
Total of 6, categorized by type of wound and treatment allocation.
Description of Study Arms:
The quality of tissue repair and scarring will be evaluated in two different, bisected post-surgical sites on the same Participant. Each wound site represents a Study Arm. Each wound site will receive two treatments, one of which is always a vehicle. In total the two wound types provide a total of 6 Study Arms for statistical analysis.
Arm 1 / Wound Type 1 (skin grafted wounds: 3-treatment groups): The wound site (injury) that requires skin grafting surgery to remove normal, uninjured skin from the same Participant to cover and repair a deep wound (a "skin graft").
Arm 2 / Wound Type (donor skin graft harvest site; 3-treatment groups): A surgical wound where a piece of normal skin is removed at uniform depth using a dermatome to harvest a skin graft ("skin graft harvest site").
The bisected wound site is randomly assigned either a control or FS2 cream treatment.
Treatment Groups: Each wound site will be used to investigate and compare three different treatments. Participants will apply the investigated treatments ("IP") as directed to allocated bisected sections of the skin grafted wound and donor wound site for 90 days. Follow-on assessments will be conducted with additional study visits on Days 180 and 270 (study endpoint).
There are four (4) differently labelled products as follows:
Treatment-1 (IP1) A single, daily application of a moisturizing cream-base.
Treatment-2 (IP2) A single, daily application of a moisturizing cream-base with FS2 (0.50% w/w).
Treatment-3 (IP3) A single, daily application of a moisturizing cream-base with FS2 (0.25% w/w). IP3 will have two different product labels to conceal the identity of the vehicle.
Control-cream (IP1), and treatments IP2 and IP3 each containing 0.50%w/w or 0.25%w/w FS2 respectively, will be topically applied to designated treatment sites once per day for a period of 90 days. Investigator and participant will be blinded from both identity of treatment product and randomized location. Each participant will be provided a different cream for each bisected-site for a total of four (4) differently labelled creams; two for the donor site, and two for the skin grafted site. Participants will discuss and be informed/reminded at each visit about study design, responsibilities, possible adverse events, proper daily wound care and cream application methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- QUADRUPLE-BLINDED, RANDOMIZED, VEHICLE-CONTROLLED STUDY INTRA-SUBJECT CONTROLS
| Arm | Type | Receives |
|---|---|---|
| Donor Site Wound, Vehicle | Sham comparator | Other: Vehicle moisture balancing baseA vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested). |
| Donor Site Wound, FS2 0.25 | Experimental | Drug: Fibrosis-Inhibiting-Compound-FS2A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested). |
| Donor Site Wound, FS2 0.5 | Experimental | Drug: Fibrosis-Inhibiting-Compound-FS2A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested) |
| Skin Graft Wound, Vehicle | Sham comparator | Other: Vehicle moisture balancing baseA vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site. |
| Skin Graft Wound, FS2 0.25 | Experimental | Drug: Fibrosis-Inhibiting-Compound-FS2A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site. |
| Skin Graft Wound, FS2 0.5 | Experimental | Drug: Fibrosis-Inhibiting-Compound-FS2A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medically able to consent to study requirements
- Adult, male and female trauma patients
- Ages 18 to 65 years of age
- Fluent in English (able to consent without a translator)
- Isolated skin wound of 3% Total Body Surface Area
Key exclusion criteria (11 listed)
- Medically unable to consent to study requirements
- Require an English translator to lawfully consent to the study and its requirements
- Treatment sights (skin graft sights) located on the face and genitalia
- Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant, or attempting to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrosis-Inhibiting-Compound-FS2Also: FS2There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base. | Drug | Donor Site Wound, FS2 0.25, Donor Site Wound, FS2 0.5, Skin Graft Wound, FS2 0.25, Skin Graft Wound, FS2 0.5 |
| Vehicle moisture balancing baseAlso: VehicleVehicle base without FS2. | Other | Donor Site Wound, Vehicle, Skin Graft Wound, Vehicle |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: 0-9 months
Differences in clinical scale scoring of healing, complications and scar severity using Vancouver Scar Scale. Investigator assessment of target scar or keloid using the Vancouver Scar Scale (VSS). Scale parameters include: Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), and Height (0-3). Scale measurements include: minimum score of 0 = normal to a maximum score of 2, 3 or 5 depending on the parameter measured.
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 0-9 months
Differences in clinical scale scoring of healing, complications and scar severity using Patient and Observer Scar Assessment Scale (POSAS). Investigator assessment of target scar or keloid using the Patient and Observer Scar Assessment Scale (POSAS). Scale parameters include: Vascularity, Pigmentation, Thickness, Relief, Pliability, and Surface Area. Scale measurements include: minimum score of 1 = normal skin to a maximum score of 10 = worst scar imaginable.
15 secondary outcomes
Adverse Events
Time frame: 0-9 months
Vital Signs - systolic blood pressure
Time frame: 0-9 months
Vital Signs - diastolic blood pressure
Time frame: 0-9 months
Vital Signs - Heart Rate
Time frame: 0-9 months
Vital Signs - Respiratory Rate
Time frame: 0-9 months
Vital Signs - Oral Temperature
Time frame: 0-9 months
Physical Exam Findings
Time frame: 0-9 months
Clinical Chemistry Results
Time frame: 0-9 months
Hematology Results
Time frame: 0-9 months
Urine Analysis Results
Time frame: 0-9 months
FS2 Pharmacokinetic urine analysis data
Time frame: 0-2 hours; 0-9 months
FS2 Pharmacokinetic blood analysis data
Time frame: 0-2 hours; 0-9 months
Pain Management
Time frame: 0-9months
Histology (Tissue Biopsies)
Time frame: 3 months and 9 months
Histology (Tissue Biopsies)
Time frame: 3 months and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 29421218Papp A, Hartwell R, Evans M, Ghahary A. The Safety and Tolerability of Topically Delivered Kynurenic Acid in Humans. A Phase 1 Randomized Double-Blind Clinical Trial. J Pharm Sci. 2018 Jun;107(6):1572-1576. doi: 10.1016/j.xphs.2018.01.023. Epub 2018 Feb 6.
- Individual participant dataSharing planned: No. There is no plan to disseminate individual participant data at this time, beyond what will be accessible through publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Papp, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrosis-Inhibiting-Compound-FS2 in people with Scar and Cicatrix, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Papp, MD, PhD (1.778.362.0161, anthony.papp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: 0-9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.