Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

February 22, 2022 updated by: Orit Markowitz MD, OptiSkin Medical

Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography

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)?"

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • OptiSkin Medical
        • Principal Investigator:
          • Orit Markowitz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dupixent

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.
Drug: Dupilumab
IL-4 antagonist to improve moderate-severe atopic dermatitis
Other Names:
  • Dupixent
Device: Optical Coherence Tomography
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
Other Names:
  • OCT
Device: Reflectance confocal microscopy
RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.
Other Names:
  • RCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: 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.
Baseline to 16 weeks
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
Time Frame: 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.
Baseline to 16 weeks
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
Time Frame: 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.
Baseline to 16 weeks
Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
Time Frame: 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
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OptiSkin Medical

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Orit Markowitz, MD, Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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