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Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

O

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

Trial contacts and locations

1

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Central trial contact

Orit Markowitz, MD; Moshe Bressler, DO

Data sourced from clinicaltrials.gov

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