Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab (NEMOSKIN)
Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Nemolizumab is a a humanised anti-IL-31 monoclonal antibody that has proven to be effective and well-tolerated for the treatment of patients with moderate-to-severe AD. Reflectance confocal microscopy (RCM) is a noninvasive procedure that allows to evaluate epidermis and papillary dermis at a cellular level. RCM allows skin structural and inflammatory parameters evaluation.
The aim of this study is to evaluate by RCM skin modifications of AD patients treated with nemolizumab.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习地点
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Drôme
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Romans-sur-Isère、Drôme、法国、26100
- 招聘中
- Hopitaux Drome NOrd
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接触：
- François Skowron, MD
- 电话号码：+33 0475054680
- 邮箱：f.skowron@ch-hdn.fr
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接触：
- Marina Bert, miss
- 电话号码：+33 +0475054698
- 邮箱：m.bert@ch-hdn.fr
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首席研究员：
- François Skowron, MD
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- 年长者
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描述
Inclusion Criteria:
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with nemolizumab
- Patients affiliated with or entitled to a social security scheme.
- Patients capable of giving informed consent.
- Patients who have received informed information about the study and have co-signed an informed consent form for participation in the study, along with the investigator.
Exclusion Criteria:
- Patients who refuse to participate in the study and legally incapacitated adults
- Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment.
- Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Thickness of the atopic skin
大体时间：at week 16
|
µm, measured by Reflectance Confocal Microscopy (RCM)
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at week 16
|
合作者和调查者
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上次提交的符合 QC 标准的更新
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其他研究编号
- 2026-A00585-46
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