Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- OCT (clinical)
研究概览
简要总结
OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).
详细描述
Psoriasis often affects the fingernails, making them yellow, brittle, painful and prone to infections. These symptoms can be difficult to manage, so OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).
OCT is being studied as a way to better diagnosis psoriatic nail disease, monitor response to therapy, and identify changes even before they become apparent, potentially leading to earlier treatment or prevention of future psoriatic arthritis.
Study-related care and medication are provided at no cost, and reimbursement for reasonable local transportation may be available to qualified individuals.
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
- •Moderate to severe psoriasis
- •Psoriasis affecting the fingernails
排除标准
- •Previous treatment with Enbrel® (etanercept)
- •Active infection
- •Rheumatoid arthritis
- •Any personal or family history of any neurologic demyelinating disease
- •Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit
研究组 & 干预措施
Etanercept
50mg etanercept subcutaneously twice weekly for 3 months, followed by once weekly for another 3 months for a total duration of 6 months or 24 weeks.
干预措施: Etanercept (Drug)
Etanercept
50mg etanercept subcutaneously twice weekly for 3 months, followed by once weekly for another 3 months for a total duration of 6 months or 24 weeks.
干预措施: OCT (Device)
结局指标
主要结局
OCT (clinical)
时间窗: Baseline to 24 weeks
Optical Coherence Tomography is noninvasive imaging that can be used to monitor nail disease severity.
NAPSI
时间窗: Baseline to 24 weeks
Nail Psoriasis Severity Index (NAPSI) score is an established measure of nail disease ranging from 0-100. A higher score indicates more severe nails psoriasis.
次要结局
- OCT (sub-clinical)(Baseline to 24 weeks)
- Dermoscopy(Baseline to 24 weeks)
研究者
Orit Markowitz MD
Chief Medical Ofiicer
OptiSkin Medical