Atopic DermatitisPAUPIADNCT04826744
Frequency of Palpebral Involvement in Adult With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by University Hospital, Lille at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Standard dermatology consultation
- How many people
- 550 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2021to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Atopic Dermatitis according to the revised Hanifin and Rakja criteria (UK Working Party)
- Oral consent
- Valid social insurance
Who cannot join
- Personal history of uncontrolled asthma
- No social insurance
- Protective measures
- Age under 18
- Pregnancy or breast-feeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
- Recruiting
Hopital Charles Nicolle Chu Rouen
Rouen
About this study
Official title: 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.
Read more
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
- Being tested
- Standard dermatology consultation
- Keywords
- Atopic eczema, palpebral dermatitis, patch-testing, ophthalmology, allergology, atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dermatology consultationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Adults with palpebral involvement of atopic dermatitis | Not described Receives: Other: Standard dermatology consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
Measured: At Baseline, the initial consultation of dermatology
Secondary outcomes (9)
Clinical description of the palpebral involvement : acute eczema or chronic eczema
Measured: 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 …)
Measured: 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
Measured: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
Description of the sensitization profile
Measured: 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
Measured: 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
Measured: At 3 months during the time of the ophthalmologic consultation
Clinical description of the ophthalmologic involvement and OSDI scoring
Measured: At 3 months during the time of the ophthalmologic consultation
Association between allergic sensitization and ophthalmologic involvement
Measured: 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
Measured: At 3 months, at the time of the reading of the tests either at 48 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Staumont-Salle, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826744
- Sponsor's protocol ID
- 2020_15
- Other IDs
- 2020-A02373-36
- Acronym
- PAUPIAD
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Palpebral Involvement in Adult Atopic Dermatitis, in a Cohort of Patients From Lille and Rouen (France) ; a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04826744
- Acronym / sponsor ID
- PAUPIAD / 2020_15
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic eczema, palpebral dermatitis, patch-testing, ophthalmology, allergology, atopic dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with palpebral involvement of atopic dermatitis | – | Other: Standard dermatology consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Atopic Dermatitis according to the revised Hanifin and Rakja criteria (UK Working Party)
- Oral consent
- Valid social insurance
Key exclusion criteria (5 listed)
- Personal history of uncontrolled asthma
- No social insurance
- Protective measures
- Age under 18
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard dermatology consultationwith 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) | Other | Adults with palpebral involvement of atopic dermatitis |
Primary outcome
Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease
Time frame: At Baseline, the initial consultation of dermatology
9 secondary outcomes
Clinical description of the palpebral involvement : acute eczema or chronic eczema
Time frame: 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
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
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
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
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
Clinical description of the ophthalmologic involvement and OSDI scoring
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Staumont-Salle, MD,PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Staumont-Salle, MD,PhD (0320445962, delphine.salle@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of palpebral involvement in adult atopic dermatitis patients, regardless the severity of the disease (time frame: At Baseline, the initial consultation of dermatology). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.