Scar Clinical Trial
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.
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.
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