EUCTR2021-004750-39-DK进行中（未招募）1 期
The role of Interleukin-1B targeted therapy for patients suffering with allergic contact dermatitis: A randomized controlled trial with Anakinra vs. Placebo.
Herlev Gentofte Hospital - Department of Dermatology and Allergy0 个研究点目标入组 22 人开始时间: 2022年1月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 1-4.
- •Able to speak and understand Danish
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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 0
- •Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0
- •Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
- •Dermatitis and/or infection on their lower back
- •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.
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