Status:
UNKNOWN
Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
Lead Sponsor:
OptiSkin Medical
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Eczema
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 exa...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05265234
Start Date
March 1 2022
End Date
March 1 2024
Last Update
March 3 2022
Active Locations (1)
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1
OptiSkin Medical
New York, New York, United States, 10128