NCT06684522招募中1 期
Upadacitinib as a Novel Treatment for Refractory Eyelid Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Reduction in Investigator Global Assessment (IGA)
研究概览
简要总结
This study aims to assess the efficacy of upadacitinib in eyelid dermatitis that has not resolved with topical therapies and patch testing.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals age 18-70 years old with eyelid dermatitis for at least two months
- •Failure of at least one topical prescription cream for the eyelid dermatitis (steroid, pimecrolimus, tacrolimus, crisaborole, or ruxolitinib)
- •Women of reproductive potential must agree to using effective contraception during treatment and for 4 weeks following the final dose of Upadacitinib.
- •Willing and able participants that provide informed consent
- •Willing and able participants that comply with study activities
排除标准
- •Self-reported history of allergic response to upadacitinib
- •Subject with self-reported history of heart disease, stroke, or neurological conditions
- •Currently taking topical medications for eyelid dermatitis within one week of starting study drug
- •Women who are pregnant, nursing, or who may become pregnant during the study
- •Non-English-speaking subjects
- •Patients with an active serious infection
- •Patients with active TB or latent TB, patients should be tested for TB prior to upadacitinib treatment.
- •Patients with active HBV/HCV or abnormal lab ranges, Lab Data: Hb<8g/dL, ALC<500 cells/mm3 and ANC <1000 cells/mm3
- •Patients with a history of malignancy within the last 5 years other than successfully treated NMSC.
研究组 & 干预措施
Upadacitinib Treatment
Experimental
Participants on upadacitinib 15mg daily
干预措施: Upadacitinib 15 MG (Drug)
结局指标
主要结局
Reduction in Investigator Global Assessment (IGA)
时间窗: 12 weeks
Reduction in baseline IGA score at week 12 compared to week 0
次要结局
未报告次要终点
研究者
Walter Liszewski
Principal Investigator
Northwestern University
研究点 (1)
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