12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
研究概览
简要总结
This study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. NFX-179 has been shown in animal studies and in human extracts to suppress p-ERK with systemic absorption of NFX-179 following topical application to be extremely low, based on serum values observed in animal studies.
Primary objectives:
- To determine the pharmacodynamic activity of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target EN in treatment group after 12 weeks of once-daily (QD) application
- To determine the safety and tolerability of treatment with NFX-179 Gel 1.50% applied QD for 12 weeks.
Secondary objectives:
-Clinical effect of NFX-179 Gel 1.5% defined as the percent change in EN volume after 12 weeks of QD application
详细描述
This is a 12-week clinical study to determine safety, tolerability, and clinical effect of NFX-179 Gel 1.50% Gel in subjects with EN.
At Visit 1 (Screening), the Investigator will select 1 Target EN lesion for treatment that meet the inclusion criteria. A biopsy tissue sample of the Target EN will be taken for histological confirmation of an EN diagnosis if required, to assess p-ERK levels and for genetic testing.
Subjects will be seen at Visit 2 for management of the Visit 1 biopsy wounds.
At Visit 3 (Baseline) eligible subjects will be provided study medication and start the 12-week, QD treatment period. Target EN assessments will be collected.
Subjects will be seen for treatment period visits, Visits 4-7, when Target EN assessments will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients receiving NFX-179 Gel
NFX-179 Gel 1.50% applied QD for 12 weeks
干预措施: NFX-179 Gel 1.50% (Drug)
结局指标
主要结局
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
时间窗: 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0
时间窗: 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
次要结局
- Change in ILA (Investigator's Lesion Assessment)(12 weeks)
- Percent change in EN volume(12 weeks)
研究者
Albert Chiou
Clinical Associate Professor
Stanford University