Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails - a Proof-of-concept, Single-center, Prospective, Open-label, Randomized, Clinical Trial With an Intra-individual Comparison of Treatments
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
研究概览
简要总结
The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.
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
- 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
Laser-assisted Enstilar delivery
Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
干预措施: Enstilar (Drug)
Laser-assisted Enstilar delivery
Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
干预措施: Ablative fractional laser (Device)
Enstilar
Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
干预措施: Enstilar (Drug)
结局指标
主要结局
Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis
时间窗: Day1 : Week 24
Change from baseline to end of treatment in N-NAIL score per nail for each treatment
次要结局
- Safety profile and local tissue response to laser treatment and Enstilar® application(Day 1 : Week 24)
研究者
Merete Haedersdal
Sponsor-Investigator [Consultant in dermatology, Clinical professor]
Bispebjerg Hospital