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

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ClinicalTrials.gov Identifier: NCT04066998
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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
Conjunctival Diseases Atopic Dermatitis Side Effect Other: Tears sampling Other: Lashes sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Conjunctivitis
Patients treated with Dupilumab with conjunctivitis
Other: Tears sampling
Tears sampling

Other: Lashes sampling
Lashes sampling

No conjunctivitis
Patients treated with Dupilumab and showing no signs of ocular involvement
Other: Tears sampling
Tears sampling

Other: Lashes sampling
Lashes sampling




Primary Outcome Measures :
  1. Increase of lacrimal inflammatory cytokines [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0 ]
    Presence of demodex on lashes before treatment with Dupilumab

  3. Increase of lacrimal eosinophiles [ Time Frame: Month 8 ]
  4. Improvement of quality of life [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066998


Contacts
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Contact: Louise VUILLEMEY, Int 033381669454 louise.vuillemey@orange.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Camille FEBVAY, MD CHU de Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04066998    
Other Study ID Numbers: P/2019/424
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctival Diseases
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Eye Diseases