NCT04186273

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scar
• Cicatrix
• Hypertrophic Scar
• Skin Graft Scar
• Skin Graft Complications
• Donor Site Complication
• Keloid

Interventions

Type	Name	Description
DRUG	Fibrosis-Inhibiting-Compound-FS2	There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
OTHER	Vehicle moisture balancing base	Vehicle base without FS2.

Timeline

• Start date: 2019-12-05
• Primary completion: 2021-02-01
• Completion: 2021-03-01
• First posted: 2019-12-04
• Last updated: 2019-12-17

Locations

1 site across 1 country: Canada