NCT03036306已完成1 期
A Randomized, Placebo Controlled, Double-blind, Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
ScarX Corp1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse Events and Tolerability Assessments
研究概览
简要总结
The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the absorption and elimination of profiles of this topically applied product will be determined through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done but are considered exploratory.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female volunteers aged ≥18 - ≤65 years who have voluntarily signed and dated an Informed Consent Form (ICF).
- •Subjects with, in the opinion of the Investigator, clinically acceptable results at screening for the laboratory tests specified in the trial protocol.
- •Women of child bearing potential must provide a negative pregnancy serum/urine test at time of screening and have to be compliant with an effective form of birth control throughout the entire study.* Non-child bearing potential means subjects have had a history of tubal ligation or a hysterectomy or are post-menopausal with no menses for at least 1 year prior to enrolment in the study.
- •Subjects, who are, in the opinion of the Investigator, able to understand the study, co- operate with the study procedures and are willing to return to the clinic for all of the required follow-up visits.
- •Subjects must be able to cooperate with requirements of the study (e.g. able to speak, read and write English, expect to be available for adverse event monitoring for the duration of the study).
排除标准
- •Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment site.
- •Subjects with a history or family history of keloid formation.
- •Subjects with a concurrent illness or condition that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing.
- •Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
- •Subjects with a body mass index <15 or >35 kg/m
- •A history of radiotherapy to the study scar area.
- •Subjects who have used nicotine-containing products (including vaping) within one month prior to the screening visit.
- •Subjects who are positive for HIV, hepatitis B or C.
- •Subjects who have known sensitivities to SCX-001 Cream, structurally related compounds or any of the constituents of SCX-001 Cream.
- •Subjects who have known sensitivities to EMLA cream, chlorhexidine or adhesive dressings
- •Subjects with a history of any malignancy in the five years prior to the screening visit.
- •Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc.).
- •Subjects with planned major surgical intervention during the course of the study.
- •Subjects who have received corticosteroids, immunosuppressive agents, anticoagulants, radiation therapy or chemotherapy at a dose that might have interfered with wound healing within the last 90 days prior to study enrolment.
- •Subjects who have received NSAIDS or ASA in the past week.
- •Subjects with a creatinine clearance of 80 ml/min or less.
研究组 & 干预措施
1.0 % SCX-001 cream
Experimental
Subjects randomized to this arm will have one lateral hip wound treated with 1.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated
干预措施: SCX-001 (Drug)
3.0% SCX-001 cream
Experimental
Subjects randomized to this arm will have one lateral hip wound treated with 3.0% SCX-001 cream and one wound treated with placebo. Intra-subject hip wound treatment is randomly allocated
干预措施: SCX-001 (Drug)
Placebo cream
Placebo Comparator
Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of Adverse Events and Tolerability Assessments
时间窗: 4 months
Adverse events, Tolerability assessments
次要结局
- Scar Size(4 months)
- Scar Quality(4 months)
- Time to Wound Closure(4 months)
- Area under the plasma concentration-time curve (AUC)(4 weeks)
- Time to reach maximum observed plasma concentration (Tmax)(4 weeks)
- Maximum observed plasma concentration (Cmax)(4 weeks)
- Gene expression analysis(Done on the day of the last dose of treatment (20 days following wounding))
- Histological analysis(Done on the day of the last dose of treatment (20 days following wounding))
- Collagen orientation analysis(Done on the day of the last dose of treatment (20 days following wounding))
- Overall Satisfaction(4 months)
研究者
研究点 (1)
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