Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.
FS2
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.
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedStudy Start
First participant enrolled
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedDecember 17, 2019
December 1, 2019
1.2 years
November 15, 2019
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
0-9 months
Secondary Outcomes (15)
Adverse Events
0-9 months
Vital Signs - systolic blood pressure
0-9 months
Vital Signs - diastolic blood pressure
0-9 months
Vital Signs - Heart Rate
0-9 months
Vital Signs - Respiratory Rate
0-9 months
- +10 more secondary outcomes
Study Arms (6)
Donor Site Wound, Vehicle
SHAM COMPARATORA 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
EXPERIMENTALA 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
EXPERIMENTALA 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 COMPARATORA vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.
Skin Graft Wound, FS2 0.25
EXPERIMENTALA 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
EXPERIMENTALA moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site.
Interventions
There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
Vehicle base without FS2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VGH Burn Unit
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (1)
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.
PMID: 29421218BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Papp, MD, PhD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- PRINCIPLE INVESTIGATOR/ INVESTIGATORS/ SPONSOR/ OUTCOME ASSESSOR/ PATIENT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, BCPFF Burn Unit and Clinical Professor
Study Record Dates
First Submitted
November 15, 2019
First Posted
December 4, 2019
Study Start
December 5, 2019
Primary Completion
February 1, 2021
Study Completion
March 1, 2021
Last Updated
December 17, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share
There is no plan to disseminate individual participant data at this time, beyond what will be accessible through publication.