A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Scarless Labs Observer Scale
研究概览
简要总结
Multi-center, dose-regimen, double-blind study evaluating the safety and efficacy of 4 doses of SLI-F06 compared with vehicle for improvement in scar appearance
详细描述
The is a Phase IIa dose-regimen study of small punch biopsy scars created on the upper and lower back of healthy patients. All excisions will be randomized to treatment with vehicle or 4 doses of SLI-F06 drug product. Patients will be divided into 3 cohorts, with Cohort B receiving the same doses as Cohort A but daily for a total of 5 days. Cohort C will receive up to twice the concentration of Cohort A potentially divided into 2 doses, with both cohorts treated only on treatment Day 0. Scars will be assessed for improvement by both the investigator and the patient at follow-up visits over 6-9 months.
Duration of study-approximately 7-10 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy subjects, male or female, ages 18 to 65
- •Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
- •Subjects with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left scapular lines.
- •Be able to follow study instructions and likely to complete all required visits.
- •Sign the Institutional Review Board (IRB)-approved informed consent form (ICF, which includes the Photographic and Video Release Form) prior to any study-related procedures being performed.
排除标准
- •Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
- •Subjects who were previously treated with SLI-F06
- •Subjects with evidence of hypertrophic or keloid scarring
- •Subjects with obvious back abnormalities (e.g., severe scoliosis)
- •Subjects with tattoos or previous scars in the study areas
- •Subjects who are poor surgical candidates
- •Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
- •History of clinically significant bleeding disorder or coagulation disorders
- •Use of any tobacco/inhaled nicotine products including vaping within 12 months.
- •Subjects with evidence of skin infection or rash on the back
- •Subjects with history of active or uncontrolled skin disease (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer) that could interfere with the study or interpretation of the study outcomes
- •Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
- •Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
- •Subjects who are taking or have taken known anticoagulants:
- •Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
- •Others such as aspirin or aspirin containing products, Non-steroidal anti-inflammatory drugs (NSAIDs), vitamin E, fish oil within 14 days prior to day
- •Subjects taking systemic or topical steroids within 4 weeks of Day 0
- •Subjects with excessive alcohol use, defined as >28 units of alcohol per week (1unit = 8 g alcohol, 1shot spirits, half- pint beer, or 5 oz wine)
- •Subjects who have evidence of drug abuse
- •Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
- •Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
- •Subjects treated with an investigational drug or device within 30 days prior to day 0
- •Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study
研究组 & 干预措施
Cohort A
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure:
- Formulation buffer (control)
- 3.75 mg SLI-F06 total dose per wound (1X)
- 7.5 mg SLI-F06 total dose per wound (2X)
- 15 mg SLI-F06 total dose per wound (4X)
干预措施: SLI-F06 (Drug)
Cohort B
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and on Days 1, 2, 3, 4:
- Formulation buffer (control)
- 3.75 mg SLI-F06 total dose per wound (1X)
- 7.5 mg SLI-F06 total dose per wound (2X)
- 15 mg SLI-F06 total dose per wound (4X)
干预措施: SLI-F06 (Drug)
Cohort C
Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and then 3 hours after for wounds dosed twice:
- Formulation buffer (control) once
- 7.5 mg SLI-F06 total dose per wound (2X) once
- 3.75 mg SLI-F06 dose per wound (1X) twice, total dose 7.5 mg
- 7.5 mg SLI-F06 total dose per wound (2X), total dose 15 mg
干预措施: SLI-F06 (Drug)
结局指标
主要结局
Change in Scarless Labs Observer Scale
时间窗: Months 1,3,6 and possibly 9
Exploratory scale for observer to assess different scar parameters, including Surface Area, Elevation / Depression, Relief, Thickness, Pliability, Vascularity and Pigmentation. The observer then makes an Overall global assessment (scale 0 to -3) of the scar based on the clinical assessment of the scar parameters. All parameters are assessed on a scale of 0-3 (except pigmentation, -3 \[hypo\] to +3 \[hyper\]), where 0 correlates to a scar that is indistinguishable from normal skin with greater deviation from 0 correlating with more severe scar. The observer creates a forced rank between scars on the upper and lower back based on best (1) to worst (4) cosmetically.
次要结局
- Patient and Observer Scar Assessment Scale (POSAS) Observer Scale(Months 1,3,6 and possibly 9)
- Scarless Labs Patient Scale(Months 1,3,6 and possibly 9)