An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.
详细描述
Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of nail psoriasis in fingernail or toenails
- •History of plaque psoriasis or psoriatic arthritis
- •Target nail will be KOH negative for dermatophyte fungus
- •Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
- •Between the ages of 18 and 85 years old
- •Candidate for topical therapy in the opinion of the investigator
排除标准
- •Males and Females unable to practice effective contraception throughout the study
- •Unable to comply with the protocol
- •Nursing mothers, pregnant women, and women planning to become pregnant while in this study
- •Patients with erythrodermic or pustular psoriasis
- •Sustained treatment to target fingernail within 6 months prior to screening
- •History of trauma or surgery to target fingernail
- •History of disease known to affect nails such as lichen planus, onychomycosis
- •History of systemic psoriasis therapy for less than 6 months
研究组 & 干预措施
Enstilar Foam
Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate).
干预措施: Enstilar Foam (Drug)
结局指标
主要结局
Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
时间窗: 24 Weeks
The target nail will be defined as the nail that has the highest nail thickness score at baseline. This nail will remain the target nail for the remainder of the study. Number of participants achieving clinical improvement as measure by the nail thickness (hyperkeratosis) measurement at week 24 compared to baseline.
次要结局
- Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline(24 weeks)
研究者
Boni Elewski
Primary Investigator
University of Alabama at Birmingham