Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

NCT ID: NCT04826744

Last Updated: 2025-12-23

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

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-06-30

Brief Summary

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Atopic dermatitis is a common inflammatory skin disease, resulting from genetical, immunological and environmental factors. Head and neck are among the most frequent involved areas, almost 50% in adult patients according to most publications. Palpebral involvement is also common and a source of major quality of life impairment for patients.

However, the real frequency of this palpebral involvement is unknown, only estimated about 20% in few studies. The treatment of this location remains difficult, regarding to the thickness of palpebral skin and proximity of the eye.

To our knowledge, no prospective studies about allergological skin tests (such as patch-tests) in atopic patients with palpebral involvement had been conducted.

Finally, atopic dermatitis is frequently associated with ophthalmological diseases such as conjunctivitis, keratoconus or cataract, which belong to the minor criteria of Hanifin and Rakja classification.

A better knowledge of the atopic dermatitis palpebral involvement and the associated factors seems to be needed to improve the treatment and the quality of life of patients

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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Atopic eczema palpebral dermatitis patch-testing ophthalmology allergology atopic dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults with palpebral involvement of atopic dermatitis

Standard dermatology consultation

Intervention Type OTHER

with clinical examination, score filling such as SCORAD and DLQI

* Standard Allergy consultation, with clinical examination, research of atopic or allergic personal and familial history
* Allergy skin testing: patch tests with the Standard European Battery and with some products bring by the patient if necessary, skin prick tests with aero allergens. Two reading of the patch tests will be performed, at H48 and H72.
* ophthalmologic consultation with slit lamp examination and OSDI (self questionnaire)

Interventions

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Standard dermatology consultation

with clinical examination, score filling such as SCORAD and DLQI

* Standard Allergy consultation, with clinical examination, research of atopic or allergic personal and familial history
* Allergy skin testing: patch tests with the Standard European Battery and with some products bring by the patient if necessary, skin prick tests with aero allergens. Two reading of the patch tests will be performed, at H48 and H72.
* ophthalmologic consultation with slit lamp examination and OSDI (self questionnaire)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Atopic Dermatitis according to the revised Hanifin and Rakja criteria (UK Working Party)
* Oral consent
* Valid social insurance

Exclusion Criteria

* Personal history of uncontrolled asthma
* No social insurance
* Protective measures
* Age under 18
* Pregnancy or breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine Staumont-Salle, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Hopital Charles Nicolle Chu Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Delphine Staumont-Salle, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2020-A02373-36

Identifier Type: OTHER

Identifier Source: secondary_id

2020_15

Identifier Type: -

Identifier Source: org_study_id