NCT00736593已完成1 期
A Phase 1 Randomized, Prospective, Within-Subject, Double-Blind, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Full-Thickness Punch Wounds
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Assessed by the incidence of adverse events from the time of application of the investigational product
研究概览
简要总结
Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects.
- •Fair skinned (Fitzpatrick Classification Level I - III).
- •Aged between 18 and 40 years inclusive.
- •Subjects who are able to comply with all study procedures, including follow-up assessment visits.
- •Subjects who are willing and able to give written informed consent to take part in the study.
排除标准
- •Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
- •Subjects who are known hypertrophic or keloid scar formers.
- •Subjects who smoke.
- •Subjects with a body mass index of greater than 30 kg/m
- •Subjects with bleeding disorders or taking anti-coagulants.
- •Subjects with any other skin lesion sites or a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or which involve the areas to be examined in this study.
- •Subjects taking or who have taken prescribed drugs in the 30 days prior to Day 0, in particular, topical or systemic steroids, anti-inflammatories, anti-coagulants, anti-proliferative drugs, or antibiotics.
- •Subjects who regularly take aspirin, ginseng, gilboa, Alka Seltzer or any other over-the-counter medicine or complimentary health product that can affect the blood clotting process.
- •Subjects with a history of clinically relevant allergies.
- •Subjects with tattoos, scars or abrasions at the site to be studied.
- •Subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination.
- •Subjects showing evidence of drug abuse.
- •Subjects with any clinically significant mental illness in the opinion of the Investigator.
- •Females who are currently pregnant or breast-feeding. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined the protocol.
- •Subjects who have a past or present disease, which as judged by the Investigator may affect the safety of the subject or the outcome of the study.
- •Subjects who have participated in a clinical study within the 30 days prior to Day 0.
研究组 & 干预措施
1
Experimental
干预措施: Nexagon™ or Nexagon™ vehicle (Drug)
结局指标
主要结局
Assessed by the incidence of adverse events from the time of application of the investigational product
时间窗: Until the end of the study.
次要结局
- Time to complete closure of the wounds(35 days post-application)
- Rate of healing(35 days post application)
- Clinical assessment by rating scales(35 days post application)
- Pain(35 days post application)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial DefectsPersistent Epithelial DefectNCT00821561OcuNexus Therapeutics, Inc.90
终止
2 期
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial DefectsPersistent Corneal Epithelial DefectsNCT01165450University of California, San Francisco2
已完成
不适用
Adjunctive Benefit of a Xenogenic Collagen MatrixGingival RecessionNCT03833765Roberto Rotundo24
已完成
2 期
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma GangrenosumPyoderma GangrenosumNCT01965613Janssen Research & Development, LLC10
尚未招募
3 期
Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe IllnessCOVID-19NCT05157243Romark Laboratories L.C.2,000