Frequency of Palpebral Involvement in Adult With Atopic Dermatitis (PAUPIAD)

December 17, 2025 updated by: University Hospital, Lille

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille
        • Contact:
          • Phone Number: 0320445962
      • Rouen, France
        • Recruiting
        • Hopital Charles Nicolle Chu Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with palpebral involvement of atopic dermatitis
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 questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
Time Frame: At Baseline, the initial consultation of dermatology
At Baseline, the initial consultation of dermatology

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical description of the palpebral involvement : acute eczema or chronic eczema
Time Frame: At Baseline, the initial consultation of dermatology
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
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
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
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
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
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
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
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
At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Delphine Staumont-Salle, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_15
  • 2020-A02373-36 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Clinical Trials on Standard dermatology consultation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe