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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
50
There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
Vehicle base without FS2.
VGH Burn Unit
Vancouver, British Columbia, Canada
RECRUITINGVancouver 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.
Time frame: 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.
Time frame: 0-9 months
Adverse Events
To evaluate and compare Treatment safety by the proportion of adverse events in each treatment arm.
Time frame: 0-9 months
Vital Signs - systolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal systolic blood pressures in each participant.
Time frame: 0-9 months
Vital Signs - diastolic blood pressure
To evaluate and compare Treatment safety by the proportion of abnormal diastolic blood pressures in participant.
Time frame: 0-9 months
Vital Signs - Heart Rate
To evaluate and compare Treatment safety by the proportion of abnormal heart rates in each participant.
Time frame: 0-9 months
Vital Signs - Respiratory Rate
To evaluate and compare Treatment safety by the proportion of abnormal respiratory rates in each participant.
Time frame: 0-9 months
Vital Signs - Oral Temperature
To evaluate and compare Treatment safety by the proportion of abnormal temperatures in each participant.
Time frame: 0-9 months
Physical Exam Findings
To evaluate and compare Treatment safety by the proportion of abnormal physical exam findings in each participant.
Time frame: 0-9 months
Clinical Chemistry Results
To evaluate and compare Treatment safety by the proportion of abnormal clinical chemistry results in each participant.
Time frame: 0-9 months
Hematology Results
To evaluate and compare Treatment safety by the proportion of abnormal hematology results for each participant.
Time frame: 0-9 months
Urine Analysis Results
To evaluate and compare Treatment safety by the proportion of abnormal urine analysis results for each participant.
Time frame: 0-9 months
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).
Time frame: 0-2 hours; 0-9 months
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).
Time frame: 0-2 hours; 0-9 months
Pain Management
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
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.
Time frame: 3 months and 9 months
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.
Time frame: 3 months and 9 months
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