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

NCT ID: NCT04066998

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2021-08-31

Brief Summary

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This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

Detailed Description

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Conditions

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Conjunctival Diseases Atopic Dermatitis Side Effect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conjunctivitis

Patients treated with Dupilumab with conjunctivitis

Group Type EXPERIMENTAL

Tears sampling

Intervention Type OTHER

Tears sampling

Lashes sampling

Intervention Type OTHER

Lashes sampling

No conjunctivitis

Patients treated with Dupilumab and showing no signs of ocular involvement

Group Type OTHER

Tears sampling

Intervention Type OTHER

Tears sampling

Lashes sampling

Intervention Type OTHER

Lashes sampling

Interventions

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Tears sampling

Tears sampling

Intervention Type OTHER

Lashes sampling

Lashes sampling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille FEBVAY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Central Contacts

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Louise VUILLEMEY, Int

Role: CONTACT

033381669454

Other Identifiers

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P/2019/424

Identifier Type: -

Identifier Source: org_study_id

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