Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"
详细描述
Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
- •IGA score ≥3, on the IGA scale of 0-4 at baseline
- •Eczema Area and Severity Index (EASI) score of ≥16 at baseline
排除标准
- •Prior treatment with Dupilumab (REGN668/SAR231893)
- •Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
- •Bodyweight <30 kg (65lb) at Baseline
- •Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection
- •Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study
研究组 & 干预措施
Dupixent
Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.
Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit.
干预措施: Dupilumab (Drug)
Dupixent
Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.
Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit.
干预措施: Optical Coherence Tomography (Device)
Dupixent
Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.
Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit.
干预措施: Reflectance confocal microscopy (Device)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: Baseline to 16 weeks
The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe.
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
时间窗: Baseline to 16 weeks
Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe.
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
时间窗: Baseline to 16 weeks
Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin. An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following \*features: * Spongiosis * Parakeratosis * Epidermal thickness * Quality of honeycomb structure of the stratum spinosum * Appearance of the dermal-epidermal junction * Appearance of the superficial dermis * Recognition of the dermal papilla * Caliber of blood vessels * Presence of inflammatory cells * Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.
Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
时间窗: Baseline to 16 weeks
Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study. The following features will be aggregated to form an Optical Coherence Tomography-severity-score: * Change in the epidermal thickness * Changes in anatomy or appearance of the dermo-epidermal junction and the dermis. * Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography * Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe
次要结局
未报告次要终点
研究者
Orit Markowitz MD
Medical Director
OptiSkin Medical