Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of cutaneous blood flow
研究概览
简要总结
The purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.
详细描述
Digital ulcerations are a complication of systemic sclerosis (SSc). Available treatments (i.e. IV iloprost) induce major adverse effects, limiting the use of such therapies. Iontophoresis is a non invasive route of administration of drugs. In experimental and clinical preliminary studies, the investigators have shown that iontophoresis of treprostinil on the forearm of healthy subjects induces a sustained increase in skin blood flux and that it is well tolerated (clinicaltrials.gov NCT01082484, manuscript in press). The investigators therefore aim at validating this proof of concept on the digits of SSc patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cutaneous systemic scleroderma with sclerosed fingers
排除标准
- •pregnant or breast-feeding women
- •any chronic disease (in the control group)
研究组 & 干预措施
Cutaneous iontophoresis of Treprostenil
干预措施: Cutaneous iontophoresis of treprostinil (Drug)
Cutaneous iontophoresis of placebo
干预措施: Cutaneous iontophoresis of treprostinil (Drug)
结局指标
主要结局
Area under the curve (AUC) of cutaneous blood flow
时间窗: 0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h
Cutaneous blood flow assessed with Laser Speckle Contrast Imaging (LSCI)
次要结局
- Treprostinil blood concentration(0, 15min, 30 min, 1h, 2h, 4h, 6h, 8h, 10h)
- Treprostinil dermal concentration(1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h)