Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04276623

Enrollment

150

Registered

2020-02-19

Start date

2020-02-25

Completion date

2023-12-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Dupilumab, Dupixent, Conjunctivitis, Bioday

Brief summary

Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .

Exclusion criteria

* Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Design outcomes

Primary

Measure	Time frame	Description
Relationship between goblet cell density and the incidence of conjunctivitis over time	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	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.
Relationship between goblet cell density and the risk of conjunctivitis	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	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.

Secondary

Measure	Time frame	Description
Conjunctival changes during dupilumab treatment using Impression Cytology	baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment	Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients
Optimal treatment of conjunctivitis	at the moment of the development of eye symptoms, 4 weeks after ocular treatment	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.

Countries

Netherlands

Contacts

Primary ContactRoselie Achten, MD

r.e.achten@umcutrecht.nl0031 88 75 57439

Backup ContactMarjolein de Bruin-Weller, MD, PhD

m.s.debruin-weller@umcutrecht.nl

Outcome results