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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Unknown status
CT.gov ID
NCT04066998
Collaborator
(none)
15
Enrollment
2
Arms
20
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Tears sampling
  • Other: Lashes sampling
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conjunctivitis

Patients treated with Dupilumab with conjunctivitis

Other: Tears sampling
Tears sampling

Other: Lashes sampling
Lashes sampling
Other: No conjunctivitis

Patients treated with Dupilumab and showing no signs of ocular involvement

Other: Tears sampling
Tears sampling

Other: Lashes sampling
Lashes sampling

Outcome Measures

Primary Outcome Measures

  1. Increase of lacrimal inflammatory cytokines [Month 8]

    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

  1. Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups [Month 8]

    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.

  2. Absence/Presence of demodex [Day 0]

    Presence of demodex on lashes before treatment with Dupilumab

  3. Increase of lacrimal eosinophiles [Month 8]

  4. Improvement of quality of life [Month 8]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Camille FEBVAY, MD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04066998
Other Study ID Numbers:
  • P/2019/424
First Posted:
Aug 26, 2019
Last Update Posted:
Nov 18, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Dermatitis, Atopic
Dermatitis

Study Results

No Results Posted as of Nov 18, 2019