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)?"
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
IL-4 antagonist to improve moderate-severe atopic dermatitis
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.
OptiSkin Medical
New York, New York, United States
RECRUITINGEczema Area and Severity Index (EASI)
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.
Time frame: Baseline to 16 weeks
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
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.
Time frame: Baseline to 16 weeks
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
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.
Time frame: Baseline to 16 weeks
Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
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
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Time frame: Baseline to 16 weeks