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.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale (VSS)
研究概览
简要总结
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.
详细描述
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").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
PRINCIPLE INVESTIGATOR/ INVESTIGATORS/ SPONSOR/ OUTCOME ASSESSOR/ PATIENT
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically able to consent to study requirements
- •Adult, male and female trauma patients
- •Ages 18 to 65 years of age
- •Fluent in English (able to consent without a translator)
- •Isolated skin wound of 3% Total Body Surface Area
- •Participant requires partial thickness skin graft (meshed/non-meshed), face and genitalia excluded.
- •Grafted skin is between 100 cm2 and 600 cm2
- •Maximum skin graft expansion ratio is 1:1.5
排除标准
- •Medically unable to consent to study requirements
- •Require an English translator to lawfully consent to the study and its requirements
- •Treatment sights (skin graft sights) located on the face and genitalia
- •Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- •Pregnant, or attempting to become pregnant
- •Known immunosuppression or immunosuppressive illness
- •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.
- •Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness
- •Subjects who smoke more than 20 cigarettes a day
- •Subjects who demonstrated evidence of drug abuse
- •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.
研究组 & 干预措施
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).
干预措施: Vehicle moisture balancing base (Other)
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).
干预措施: Fibrosis-Inhibiting-Compound-FS2 (Drug)
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)
干预措施: Fibrosis-Inhibiting-Compound-FS2 (Drug)
Skin Graft Wound, Vehicle
A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.
干预措施: Vehicle moisture balancing base (Other)
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.
干预措施: Fibrosis-Inhibiting-Compound-FS2 (Drug)
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.
干预措施: Fibrosis-Inhibiting-Compound-FS2 (Drug)
结局指标
主要结局
Vancouver Scar Scale (VSS)
时间窗: 0-9 months
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.
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 0-9 months
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.
次要结局
- FS2 Pharmacokinetic blood analysis data(0-2 hours; 0-9 months)
- Pain Management(0-9months)
- Histology (Tissue Biopsies)(3 months and 9 months)
- Adverse Events(0-9 months)
- Vital Signs - systolic blood pressure(0-9 months)
- Vital Signs - diastolic blood pressure(0-9 months)
- Vital Signs - Heart Rate(0-9 months)
- Vital Signs - Respiratory Rate(0-9 months)
- Vital Signs - Oral Temperature(0-9 months)
- Physical Exam Findings(0-9 months)
- Clinical Chemistry Results(0-9 months)
- Hematology Results(0-9 months)
- Urine Analysis Results(0-9 months)
- FS2 Pharmacokinetic urine analysis data(0-2 hours; 0-9 months)
研究者
Anthony Papp
Medical Director, BCPFF Burn Unit and Clinical Professor
University of British Columbia