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NCT04066998 Clinical Trial

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

Atopic Dermatitis Clinical Trial

— CYCLADDE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04066998
Other study ID # P/2019/424
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2019
Est. completion date August 2021

Study information
Verified date August 2019
Source Centre Hospitalier Universitaire de Besancon
Contact Louise VUILLEMEY, Int
Phone 033381669454
Email louise.vuillemey@orange.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date August 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tears sampling
Tears sampling
• Lashes sampling
Lashes sampling

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary 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 ß, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon a, Tumor Necrosis Factor a. Month 8
Secondary 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 ß, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interferon a, Tumor Necrosis Factor a. Month 8
Secondary Absence/Presence of demodex Presence of demodex on lashes before treatment with Dupilumab Day 0
Secondary Increase of lacrimal eosinophiles Month 8
Secondary 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) Month 8
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