Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
- Conditions
- EczemaAtopic Dermatitis
- Interventions
- Registration Number
- NCT05265234
- Lead Sponsor
- OptiSkin Medical
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dupixent Optical Coherence Tomography 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. Dupixent Reflectance confocal microscopy 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. Dupixent Dupilumab 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OptiSkin Medical
🇺🇸New York, New York, United States