Scar Clinical Trial
— FS2Official 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | VGH Burn Unit | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0-9 months | |
Primary | 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. | 0-9 months | |
Secondary | Adverse Events | To evaluate and compare Treatment safety by the proportion of adverse events in each treatment arm. | 0-9 months | |
Secondary | Vital Signs - systolic blood pressure | To evaluate and compare Treatment safety by the proportion of abnormal systolic blood pressures in each participant. | 0-9 months | |
Secondary | Vital Signs - diastolic blood pressure | To evaluate and compare Treatment safety by the proportion of abnormal diastolic blood pressures in participant. | 0-9 months | |
Secondary | Vital Signs - Heart Rate | To evaluate and compare Treatment safety by the proportion of abnormal heart rates in each participant. | 0-9 months | |
Secondary | Vital Signs - Respiratory Rate | To evaluate and compare Treatment safety by the proportion of abnormal respiratory rates in each participant. | 0-9 months | |
Secondary | Vital Signs - Oral Temperature | To evaluate and compare Treatment safety by the proportion of abnormal temperatures in each participant. | 0-9 months | |
Secondary | Physical Exam Findings | To evaluate and compare Treatment safety by the proportion of abnormal physical exam findings in each participant. | 0-9 months | |
Secondary | Clinical Chemistry Results | To evaluate and compare Treatment safety by the proportion of abnormal clinical chemistry results in each participant. | 0-9 months | |
Secondary | Hematology Results | To evaluate and compare Treatment safety by the proportion of abnormal hematology results for each participant. | 0-9 months | |
Secondary | Urine Analysis Results | To evaluate and compare Treatment safety by the proportion of abnormal urine analysis results for each participant. | 0-9 months | |
Secondary | 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). | 0-2 hours; 0-9 months | |
Secondary | 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). | 0-2 hours; 0-9 months | |
Secondary | Pain Management | Pain Visual Analog Scale longitudinal comparison of subjective changes for each participant. Pain, Visual analog scale (score 0-none to 10-worse) |
0-9months | |
Secondary | 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. | 3 months and 9 months | |
Secondary | 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. | 3 months and 9 months |
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