Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

Официальное название

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

Обзор

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

Вмешательства

• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (9)

• Clinical description of the palpebral involvement : acute eczema or chronic eczema [Срок оценки: 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 …) [Срок оценки: 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 [Срок оценки: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]
• Description of the sensitization profile [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At 3 months during the time of the ophthalmologic consultation]
• Clinical description of the ophthalmologic involvement and OSDI scoring [Срок оценки: At 3 months during the time of the ophthalmologic consultation]
• Association between allergic sensitization and ophthalmologic involvement [Срок оценки: 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 [Срок оценки: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Hop Claude Huriez Chu Lille — Lille
• Hopital Charles Nicolle Chu Rouen — Rouen

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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