Frequency of Palpebral Involvement in Adult With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— PAUPIAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826744
• Other study ID #: 2020_15
• Secondary ID: 2020-A02373-36
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: Delphine Staumont-Salle, MD,PhD
• Phone: 0320445962
• Email: delphine.salle[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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)

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille
France	Hopital Charles Nicolle Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease		At Baseline, the initial consultation of dermatology
Secondary	Clinical description of the palpebral involvement : acute eczema or chronic eczema		At Baseline, the initial consultation of dermatology
Secondary	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
Secondary	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
Secondary	Description of the sensitization profile		At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
Secondary	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
Secondary	Rate of ophthalmologic comorbidities in association with palpebral involvement of the atopic dermatitis		At 3 months during the time of the ophthalmologic consultation
Secondary	Clinical description of the ophthalmologic involvement and OSDI scoring		At 3 months during the time of the ophthalmologic consultation
Secondary	Association between allergic sensitization and ophthalmologic involvement		At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
Secondary	Association between ophthalmologic involvement 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