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Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2. (FS2)

Primary Purpose

Scar, Cicatrix, Hypertrophic Scar

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fibrosis-Inhibiting-Compound-FS2
Vehicle moisture balancing base
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scar

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Medically able to consent to study requirements
  2. Adult, male and female trauma patients
  3. Ages 18 to 65 years of age
  4. Fluent in English (able to consent without a translator)
  5. Isolated skin wound of 3% Total Body Surface Area
  6. Participant requires partial thickness skin graft (meshed/non-meshed), face and genitalia excluded.
  7. Grafted skin is between 100 cm2 and 600 cm2
  8. Maximum skin graft expansion ratio is 1:1.5

Exclusion Criteria:

  1. Medically unable to consent to study requirements
  2. Require an English translator to lawfully consent to the study and its requirements
  3. Treatment sights (skin graft sights) located on the face and genitalia
  4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
  5. Pregnant, or attempting to become pregnant
  6. Known immunosuppression or immunosuppressive illness
  7. 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.
  8. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness
  9. Subjects who smoke more than 20 cigarettes a day
  10. Subjects who demonstrated evidence of drug abuse
  11. 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.

Sites / Locations

  • VGH Burn UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Sham Comparator

Experimental

Experimental

Sham Comparator

Experimental

Experimental

Arm Label

Donor Site Wound, Vehicle

Donor Site Wound, FS2 0.25

Donor Site Wound, FS2 0.5

Skin Graft Wound, Vehicle

Skin Graft Wound, FS2 0.25

Skin Graft Wound, FS2 0.5

Arm Description

A vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested).

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).

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)

A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.

A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site.

A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Adverse Events
To evaluate and compare Treatment safety by the proportion of adverse events in each treatment arm.
Vital Signs - systolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal systolic blood pressures in each participant.
Vital Signs - diastolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal diastolic blood pressures in participant.
Vital Signs - Heart Rate
To evaluate and compare Treatment safety by the proportion of abnormal heart rates in each participant.
Vital Signs - Respiratory Rate
To evaluate and compare Treatment safety by the proportion of abnormal respiratory rates in each participant.
Vital Signs - Oral Temperature
To evaluate and compare Treatment safety by the proportion of abnormal temperatures in each participant.
Physical Exam Findings
To evaluate and compare Treatment safety by the proportion of abnormal physical exam findings in each participant.
Clinical Chemistry Results
To evaluate and compare Treatment safety by the proportion of abnormal clinical chemistry results in each participant.
Hematology Results
To evaluate and compare Treatment safety by the proportion of abnormal hematology results for each participant.
Urine Analysis Results
To evaluate and compare Treatment safety by the proportion of abnormal urine analysis results for each participant.
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).
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).
Pain Management
Pain Visual Analog Scale longitudinal comparison of subjective changes for each participant. Pain, Visual analog scale (score 0-none to 10-worse)
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.
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.

Full Information

First Posted
November 15, 2019
Last Updated
December 13, 2019
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04186273
Brief Title
Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.
Acronym
FS2
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Cicatrix, Hypertrophic Scar, Skin Graft Scar, Skin Graft Complications, Donor Site Complication, Keloid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
QUADRUPLE-BLINDED, RANDOMIZED, VEHICLE-CONTROLLED STUDY INTRA-SUBJECT CONTROLS
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
PRINCIPLE INVESTIGATOR/ INVESTIGATORS/ SPONSOR/ OUTCOME ASSESSOR/ PATIENT
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donor Site Wound, Vehicle
Arm Type
Sham Comparator
Arm Description
A vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested).
Arm Title
Donor Site Wound, FS2 0.25
Arm Type
Experimental
Arm Description
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).
Arm Title
Donor Site Wound, FS2 0.5
Arm Type
Experimental
Arm Description
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)
Arm Title
Skin Graft Wound, Vehicle
Arm Type
Sham Comparator
Arm Description
A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.
Arm Title
Skin Graft Wound, FS2 0.25
Arm Type
Experimental
Arm Description
A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site.
Arm Title
Skin Graft Wound, FS2 0.5
Arm Type
Experimental
Arm Description
A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site.
Intervention Type
Drug
Intervention Name(s)
Fibrosis-Inhibiting-Compound-FS2
Other Intervention Name(s)
FS2
Intervention Description
There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
Intervention Type
Other
Intervention Name(s)
Vehicle moisture balancing base
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle base without FS2.
Primary Outcome Measure Information:
Title
Vancouver Scar Scale (VSS)
Description
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.
Time Frame
0-9 months
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
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.
Time Frame
0-9 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
To evaluate and compare Treatment safety by the proportion of adverse events in each treatment arm.
Time Frame
0-9 months
Title
Vital Signs - systolic blood pressure
Description
To evaluate and compare Treatment safety by the proportion of abnormal systolic blood pressures in each participant.
Time Frame
0-9 months
Title
Vital Signs - diastolic blood pressure
Description
To evaluate and compare Treatment safety by the proportion of abnormal diastolic blood pressures in participant.
Time Frame
0-9 months
Title
Vital Signs - Heart Rate
Description
To evaluate and compare Treatment safety by the proportion of abnormal heart rates in each participant.
Time Frame
0-9 months
Title
Vital Signs - Respiratory Rate
Description
To evaluate and compare Treatment safety by the proportion of abnormal respiratory rates in each participant.
Time Frame
0-9 months
Title
Vital Signs - Oral Temperature
Description
To evaluate and compare Treatment safety by the proportion of abnormal temperatures in each participant.
Time Frame
0-9 months
Title
Physical Exam Findings
Description
To evaluate and compare Treatment safety by the proportion of abnormal physical exam findings in each participant.
Time Frame
0-9 months
Title
Clinical Chemistry Results
Description
To evaluate and compare Treatment safety by the proportion of abnormal clinical chemistry results in each participant.
Time Frame
0-9 months
Title
Hematology Results
Description
To evaluate and compare Treatment safety by the proportion of abnormal hematology results for each participant.
Time Frame
0-9 months
Title
Urine Analysis Results
Description
To evaluate and compare Treatment safety by the proportion of abnormal urine analysis results for each participant.
Time Frame
0-9 months
Title
FS2 Pharmacokinetic urine analysis data
Description
To obtain, evaluate and compare total urine drug concentrations for each participant and compare clearance normalized by estimated volume of distribution (Vd).
Time Frame
0-2 hours; 0-9 months
Title
FS2 Pharmacokinetic blood analysis data
Description
To obtain, evaluate and compare total blood drug concentrations for each participant and compare clearance normalized by estimated volume of distribution (Vd).
Time Frame
0-2 hours; 0-9 months
Title
Pain Management
Description
Pain Visual Analog Scale longitudinal comparison of subjective changes for each participant. Pain, Visual analog scale (score 0-none to 10-worse)
Time Frame
0-9months
Title
Histology (Tissue Biopsies)
Description
Evaluate and compare pathological assessments of punch biopsies obtained from each treatment site and compare intra site subjective findings (qualitative) for each.
Time Frame
3 months and 9 months
Title
Histology (Tissue Biopsies)
Description
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.
Time Frame
3 months and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Papp, MD, PhD
Phone
1.778.362.0161
Email
anthony.papp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Hartwell, PhD
Phone
1.778.362.5758
Email
clinicaltrials@birchbiomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Papp, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
VGH Burn Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tesnim Sairi
Phone
604-875-4095
Email
clinicaltrials@birchbiomed.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to disseminate individual participant data at this time, beyond what will be accessible through publication.
Citations:
PubMed Identifier
29421218
Citation
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.
Results Reference
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Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.

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