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Recruiting NCT04826744

Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

Observational Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard dermatology consultation.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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 question

Primary outcome measures

  • Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease [Time frame: At Baseline, the initial consultation of dermatology]
Secondary outcome measures (9)
  • Clinical description of the palpebral involvement : acute eczema or chronic eczema [Time frame: 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 …) [Time frame: 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 [Time frame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
  • Description of the sensitization profile [Time frame: 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 [Time frame: 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 [Time frame: At 3 months during the time of the ophthalmologic consultation]
  • Clinical description of the ophthalmologic involvement and OSDI scoring [Time frame: At 3 months during the time of the ophthalmologic consultation]
  • Association between allergic sensitization and ophthalmologic involvement [Time frame: 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 [Time frame: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Hop Claude Huriez Chu Lille — Lille
  • Hopital Charles Nicolle Chu Rouen — Rouen

Identifiers

NCT: NCT04826744 · 2020_15 · 2020-A02373-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗