Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Last updated: February 22, 2022
Sponsor: OptiSkin Medical
Overall Status: Active - Recruiting

Phase

4

Condition

Atopic Dermatitis

Allergy

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT05265234
OPTI-003
  • Ages > 18
  • All Genders

Study 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)?"

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Prior treatment with Dupilumab (REGN668/SAR231893)
  • Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before thebaseline 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

Total Participants: 15
Study Start date:
March 01, 2022
Estimated Completion Date:
March 01, 2024

Study 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.

Connect with a study center

  • OptiSkin Medical

    New York, New York 10128
    United States

    Active - Recruiting

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