NCT05498467已完成3 期
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical Reaction
研究概览
简要总结
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged at least eighteen years old.
- •Able to provide written informed consent.
- •Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
- •ICDRG scoring system when challenged with nickel.
- •Fitzpatrick skin type 1-
- •Able to speak and understand Danish.
排除标准
- •Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day
- •Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day
- •Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
- •Dermatitis and/or infection.
- •Recent (3 months or less) administration of a live virus vaccine.
- •Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating.
- •Taking part in any other intervention study.
- •Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use).
- •Presence of any condition or use of any medication which precludes the use of the study drug.
- •Allergy to any of the ingredients in the drug.
研究组 & 干预措施
Anakinra
Active Comparator
干预措施: Anakinra (Drug)
Placebo
Placebo Comparator
干预措施: Sodium Chloride 9mg/ml Injection (Drug)
结局指标
主要结局
Clinical Reaction
时间窗: 2 months
Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
次要结局
未报告次要终点
研究者
Kelvin Yeung
MD, Principal Investigator
Herlev and Gentofte Hospital
研究点 (1)
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