Eczema, Atopic Dermatitis
Conditions
Keywords
dermatitis, Dupilumab, Inflammatory Skin Diseases, itch relief, biologic
Brief summary
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)?
Detailed description
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.
Interventions
DRUGDupilumab
IL-4 antagonist to improve moderate-severe atopic dermatitis
DEVICEOptical Coherence Tomography
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.
Sponsors
Regeneron Pharmaceuticals
OptiSkin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 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) | 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) | 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) | 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 |
Countries
United States
Contacts
Primary ContactMoshe Bressler, DO
Backup ContactOrit Markowitz, MD
Outcome results
None listed