Clinical trial NCT04826744: Frequency of Palpebral Involvement in Adult With Atopic Dermatitis
Official title: Frequency of Palpebral Involvement in Adult Atopic Dermatitis, in a Cohort of Patients From Lille and Rouen (France) ; a Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Keywords: Atopic eczema
palpebral dermatitis
patch-testing
ophthalmology
allergology
atopic dermatitis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with atopic dermatitis. Systematic inclusion of out-patients and in-patients of the University Hospital of Lille and Rouen, but also patients from liberal physicians (dermatologists and allergists) in Lille and Rouen

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


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
timeFrame: At Baseline, the initial consultation of dermatology
Secondary outcomes:
measure: Clinical description of the palpebral involvement : acute eczema or chronic eczema
timeFrame: At Baseline, the initial consultation of dermatology
measure: Potential factors associated with palpebral involvement of the atopic dermatitis (socio-demographics factors, clinical factors, comorbidities, treatment, severity …)
timeFrame: At Baseline, (the initial consultation of dermatology ) and at 3 months during the consultation of allergology
measure: Rate of relevant contact sensitization according to the skin testing and the clinical manifestations
timeFrame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
measure: Description of the sensitization profile
timeFrame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
measure: Association between allergic sensitization and severity of the atopic dermatitis
timeFrame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
measure: Rate of ophthalmologic comorbidities in association with palpebral involvement of the atopic dermatitis
timeFrame: At 3 months during the time of the ophthalmologic consultation
measure: Clinical description of the ophthalmologic involvement and OSDI scoring
timeFrame: At 3 months during the time of the ophthalmologic consultation
measure: Association between allergic sensitization and ophthalmologic involvement
timeFrame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
measure: Association between ophthalmologic involvement and severity of the atopic dermatitis
timeFrame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Rouen
country: France
facility: Hopital Charles Nicolle Chu Rouen
Study officials:
affiliation: University Hospital, Lille
name: Delphine Staumont-Salle, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: