Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Thickness of the atopic skin
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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.
排除标准
- •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.
结局指标
主要结局
Thickness of the atopic skin
时间窗: at week 16
µm, measured by Reflectance Confocal Microscopy (RCM)
次要结局
未报告次要终点