Atopic Dermatitis, Conjunctival Diseases, Side Effect
Conditions
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
Interventions
OTHERTears sampling
Tears sampling
OTHERLashes sampling
Lashes sampling
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Absence/Presence of demodex | Day 0 | Presence of demodex on lashes before treatment with Dupilumab |
| Increase of lacrimal eosinophiles | Month 8 | — |
| 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) |
Contacts
Primary ContactLouise VUILLEMEY, Int
Outcome results
None listed