Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- The efficacy of topical 2% tofacitinib
研究概览
简要总结
To evaluate the efficacy and safety of topical 2% tofacitinib nail lacquer in nail psoriasis, using the NAPSI and DLQI scales before and after 26 weeks of treatment.
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
- •Age ≥ 18 years;
- •Presence of nail psoriasis in at least one fingernail or toenail;
- •Patients not using systemic medication, or without adequate response to systemic medication after at least 6 months of use;
- •Ability to read, understand, and sign the Informed Consent Form (ICF) and the Consent Form for Images, Presentations, and Scientific Publications.
排除标准
- •Pregnant or breastfeeding women or those planning to become pregnant during the study period;
- •History of sensitivity to any components of the study product;
- •Initiation of systemic medication for nail psoriasis less than six months prior.
研究组 & 干预措施
Medicated Nail Lacquer
干预措施: Topical 2% Tofacitinib (Drug)
结局指标
主要结局
The efficacy of topical 2% tofacitinib
时间窗: 26 weeks
The Nail Psoriasis Severity Index (NAPSI) evaluates nail psoriasis severity by assessing a target nail for nail matrix and nail bed involvement. The nail is divided into four quadrants. Nail matrix psoriasis includes pitting, leukonychia, red spots in the lunula, and nail plate crumbling, while nail bed psoriasis comprises onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and nail bed hyperkeratosis. Each component is scored from 0 to 4 according to the number of quadrants affected (1 = 1/4, 2 = 2/4, 3 = 3/4, 4 = 4/4). The total NAPSI score per nail is calculated as the sum of matrix and nail bed scores, ranging from 0 to 8. The score is directly proportional to disease severity, with higher scores indicating greater nail involvement and a score of zero representing absence of nail manifestations. In clinical studies, a decrease in NAPSI score over time indicates clinical improvement.
次要结局
- Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib(26 weeks)
研究者
Doris Hexsel
Dr
Hexsel Dermatology Clinic