Atopic Dermatitis Clinical Trial
— CYCLADDEOfficial title:
Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab
This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
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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