Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

NCT04826744 | Recruiting

• 2 other identifiers: 2020_152020-A02373-36
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 2

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

Conditions

Atopic Dermatitis

Keywords

Atopic eczema; palpebral dermatitis; patch-testing; ophthalmology; allergology; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease

  At Baseline, the initial consultation of dermatology

Secondary Outcomes (9)

• 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

Study Arms (1)

Adults with palpebral involvement of atopic dermatitis

Other: Standard dermatology consultation

Interventions

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)

Adults with palpebral involvement of atopic dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

Hopital Charles Nicolle Chu Rouen

Rouen, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Delphine Staumont-Salle, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Staumont-Salle, MD,PhD

CONTACT

0320445962; delphine.salle@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (2)