Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
CYCLADDE
1 other identifier
interventional
15
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedNovember 18, 2019
August 1, 2019
1.7 years
August 21, 2019
November 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Month 8
Secondary Outcomes (4)
Comparison of the increase of lacrimal inflammatory cytokines between the 2 groups
Month 8
Absence/Presence of demodex
Day 0
Increase of lacrimal eosinophiles
Month 8
Improvement of quality of life
Month 8
Study Arms (2)
Conjunctivitis
EXPERIMENTALPatients treated with Dupilumab with conjunctivitis
No conjunctivitis
OTHERPatients treated with Dupilumab and showing no signs of ocular involvement
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camille FEBVAY, MD
CHU de Besançon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 26, 2019
Study Start
December 1, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
November 18, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share