PAUPIAD: Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826744

Collaborator

(none)

550

Enrollment

Location

Anticipated Duration (Months)

45.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Other: Standard dermatology consultation

Study Design

Study Type:

Observational

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Frequency of Palpebral Involvement in Adult Atopic Dermatitis, in a Cohort of Patients From Lille and Rouen (France) ; a Multicenter Prospective Study

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Adults with palpebral involvement of atopic dermatitis	Other: 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)

Arm

Intervention/Treatment

Adults with palpebral involvement of atopic dermatitis

Other: 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)

Outcome Measures

Primary Outcome Measures

Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease [At Baseline, the initial consultation of dermatology]

Secondary Outcome Measures

Clinical description of the palpebral involvement : acute eczema or chronic eczema [At Baseline, the initial consultation of dermatology]
Potential factors associated with palpebral involvement of the atopic dermatitis (socio-demographics factors, clinical factors, comorbidities, treatment, severity …) [At Baseline, (the initial consultation of dermatology ) and at 3 months during the consultation of allergology]
Rate of relevant contact sensitization according to the skin testing and the clinical manifestations [At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
Description of the sensitization profile [At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
Association between allergic sensitization and severity of the atopic dermatitis [At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
Rate of ophthalmologic comorbidities in association with palpebral involvement of the atopic dermatitis [At 3 months during the time of the ophthalmologic consultation]
Clinical description of the ophthalmologic involvement and OSDI scoring [At 3 months during the time of the ophthalmologic consultation]
Association between allergic sensitization and ophthalmologic involvement [At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
Association between ophthalmologic involvement and severity of the atopic dermatitis [At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]