Recruiting
Phase 2

FS2

Sponsor:

University of British Columbia

Code:

NCT04186273

Conditions

Scar

Cicatrix

Hypertrophic Scar

Skin Graft Scar

Skin Graft Complications

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Fibrosis-Inhibiting-Compound-FS2

Vehicle moisture balancing base

Study Details

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.

Conditions

Scar

Cicatrix

Hypertrophic Scar

Skin Graft Scar

Skin Graft Complications

Study ID

NCT04186273

Start date

Dec 5, 2019

Status verified date

Dec, 2019

Completion date

Mar 1, 2021

Anticipated

Primary completion date

Feb 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

sham comparator: Donor Site Wound, Vehicle

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

experimental: Donor Site Wound, FS2 0.25

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).

experimental: Donor Site Wound, FS2 0.5

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)

sham comparator: Skin Graft Wound, Vehicle

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

experimental: Skin Graft Wound, FS2 0.25

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

experimental: Skin Graft Wound, FS2 0.5

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

Interventions

Fibrosis-Inhibiting-Compound-FS2

There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.

Vehicle moisture balancing base

Vehicle base without FS2.

Primary outcome measure

  • Vancouver Scar Scale (VSS) [ Time Frame: 0-9 months ]
  • Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 0-9 months ]

Central Contacts and Locations

Central contacts

Locations

VGH Burn Unit

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Dec 17, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2019-12-17.