Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

OptiSkin Medical

Status and phase: Unknown; Phase 4

Conditions: Atopic Dermatitis; Eczema

Treatments: Device: Reflectance confocal microscopy; Drug: Dupilumab; Device: Optical Coherence Tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05265234

OPTI-003

Details and patient eligibility

About

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)?"

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Dupixent

Experimental group

Description:

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.

Treatment:

Device: Optical Coherence Tomography

Drug: Dupilumab

Device: Reflectance confocal microscopy