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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.
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| Measure | Description | Time Frame |
|---|---|---|
| Relationship between goblet cell density and the incidence of conjunctivitis over time | Establish the relationship between goblet cell densitiy and the incidence of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly. | change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment |
| Relationship between goblet cell density and the risk of conjunctivitis | Establish the relationship between goblet cell densitiy and the risk of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly. | change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival changes during dupilumab treatment using Impression Cytology | Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients | baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roselie Achten, MD | Contact | 0031 88 75 57439 | r.e.achten@umcutrecht.nl | |
| Marjolein de Bruin-Weller, MD, PhD | Contact | m.s.debruin-weller@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Recruiting | Utrecht | 3584CX | Netherlands |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Blood, tear fluid, impression cytology of the conjunctiva
| Optimal treatment of conjunctivitis | Establish the most optimal treatment of conjunctivitis during dupilumab treatment. Ophthalmological examination will be compared at all time points to determine if the prescribed therapy is effective and optimal. | at the moment of the development of eye symptoms, 4 weeks after ocular treatment |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |