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NCT Number: NCT04826744

Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard dermatology consultation

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)

Primary outcomes

  1. 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 outcomes

  1. Clinical description of the palpebral involvement : acute eczema or chronic eczema

    Time frame: At Baseline, the initial consultation of dermatology

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Clinical description of the ophthalmologic involvement and OSDI scoring

    Time frame: At 3 months during the time of the ophthalmologic consultation

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine Staumont-Salle, MD,PhD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: PAUPIAD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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