Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    15
  • sponsor
    OptiSkin Medical
Updated on 12 March 2022
eczema
dupilumab

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)?"

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.

Details
Condition Eczema, Atopic Dermatitis
Treatment Optical Coherence Tomography, Reflectance confocal microscopy, Dupilumab
Clinical Study IdentifierNCT05265234
SponsorOptiSkin Medical
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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