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Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab (CYCLADDE)

Primary Purpose

Conjunctival Diseases, Atopic Dermatitis, Side Effect

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tears sampling
Lashes sampling
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Conjunctival Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with severe atopic dermatitis resistant to main immunosuppressive drugs
  • treated with Dupilumab
  • with or without conjunctivitis
  • postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception

Exclusion Criteria:

- pregnant or breastfeeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Conjunctivitis

    No conjunctivitis

    Arm Description

    Patients treated with Dupilumab with conjunctivitis

    Patients treated with Dupilumab and showing no signs of ocular involvement

    Outcomes

    Primary Outcome Measures

    Increase of lacrimal inflammatory cytokines
    Change in inflammatory cytokines in tears collected by capillary before and after treatment with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α.

    Secondary Outcome Measures

    Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups
    Change in inflammatory cytokines in tears collected by capillary among conjunctivitis patients versus non conjunctivitis patients, when treated with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α.
    Absence/Presence of demodex
    Presence of demodex on lashes before treatment with Dupilumab
    Increase of lacrimal eosinophiles
    Improvement of quality of life
    Improvement of quality of life for patients treated with Dupilumab, assessed with Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 (normal/no ocular involvement) to 100 (severe ocular disease)

    Full Information

    First Posted
    August 21, 2019
    Last Updated
    November 15, 2019
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04066998
    Brief Title
    Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
    Acronym
    CYCLADDE
    Official Title
    Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Conjunctival Diseases, Atopic Dermatitis, Side Effect

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conjunctivitis
    Arm Type
    Experimental
    Arm Description
    Patients treated with Dupilumab with conjunctivitis
    Arm Title
    No conjunctivitis
    Arm Type
    Other
    Arm Description
    Patients treated with Dupilumab and showing no signs of ocular involvement
    Intervention Type
    Other
    Intervention Name(s)
    Tears sampling
    Intervention Description
    Tears sampling
    Intervention Type
    Other
    Intervention Name(s)
    Lashes sampling
    Intervention Description
    Lashes sampling
    Primary Outcome Measure Information:
    Title
    Increase of lacrimal inflammatory cytokines
    Description
    Change in inflammatory cytokines in tears collected by capillary before and after treatment with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α.
    Time Frame
    Month 8
    Secondary Outcome Measure Information:
    Title
    Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups
    Description
    Change in inflammatory cytokines in tears collected by capillary among conjunctivitis patients versus non conjunctivitis patients, when treated with Dupilumab. Analysis will be performed by flow cytometry. Concentrations of the following cytokines wil be measured: interleukin-1 β, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon α, Tumor Necrosis Factor α.
    Time Frame
    Month 8
    Title
    Absence/Presence of demodex
    Description
    Presence of demodex on lashes before treatment with Dupilumab
    Time Frame
    Day 0
    Title
    Increase of lacrimal eosinophiles
    Time Frame
    Month 8
    Title
    Improvement of quality of life
    Description
    Improvement of quality of life for patients treated with Dupilumab, assessed with Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 (normal/no ocular involvement) to 100 (severe ocular disease)
    Time Frame
    Month 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with severe atopic dermatitis resistant to main immunosuppressive drugs treated with Dupilumab with or without conjunctivitis postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception Exclusion Criteria: - pregnant or breastfeeding women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Louise VUILLEMEY, Int
    Phone
    033381669454
    Email
    louise.vuillemey@orange.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Camille FEBVAY, MD
    Organizational Affiliation
    CHU de Besançon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab

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