Atopic DermatitisATOPYREGNCT06313333
National Register of Moderate and Severe Adult Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
Trial summary
Collect clinical history and treatment data of AD in adulthood; Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2020to 31 Dec 2030
- How long will I take part?
- 10 Years
- 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: The nature of the study is descriptive. Each centre undertakes to recruit all adult patients diagnosed with moderate-severe atopic dermatitis observed at the center.
Who may be able to join
- Age 18 years
- Signature of informed consent
- Diagnosis of moderate and/or severe DA by a dermatologist specialist defined on the basis of following criteria (10):
- EASI 16
- EASI <16 but with at least one of the following conditions:
- location in at least one of the following "critical" locations: face, hands, genitals
Show all 9Show fewer
- QID > 10
- VAS itching > 7
- VAS sleep > 7
Who cannot join
- Patient unable to provide informed consent prior to any collection procedures data on the study;
- unable to complete the procedures required for the study;
- a patient already participating in another follow-up register of the same disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Spedali Civili di Brescia
Brescia, Brescia, 25123
Piergiacomo MD Calzavara Pinton, 0303995305, piergiacomo.calzavarapinton@unibs.it
About this study
Official title: Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto
Collect clinical history and treatment data of AD in adulthood;
Read the detailed description
Atopic dermatitis is a chronic-recurrent inflammatory skin disease with high prevalence in children and frequently presenting clinical remission during or after childhood; however, it may persist and/or recur, even after long and transient remission, adulthood. In addition, in some adult patients, DA is not present in pediatric age, but onset in adulthood: the investigators speak, in these cases, of adult-onset DA. The prevalence of DA is increasing all over the world and the cases in which clinical manifestations appear or persist during adolescence and/or adulthood are increased especially in industrialized countries. are not currently available specific laboratory markers for diagnosis of DA and, therefore, diagnosis is eminently clinical. In fact, at the present time, there are no validated diagnostic criteria, nor is there a clear consensus on diagnostic-therapeutic pathway to be followed when evaluating patients with adult DA. For these reasons, the collection of data related to various aspects of the DA such as those epidemiological, medical and clinical history, as well as the impact of the disease on the quality of life, results of crucial importance for estimating the real prevalence of this disease in Italy and also, possibly, to outline possible diagnostic criteria specific to adult DA, so that to facilitate and improve the diagnostic-therapeutic path of the patient. The intention of the project, therefore, is to create and use a National Register dedicated to DA patients in adulthood regardless of the period of onset of their pathology. aim to place the Italian Register as a supranational reference for international studies conducted on the adult DA.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological data
Reassessment of the epidemiology of AD
Measured: from baseline through study completion, an average of 3 year
Identification of factors for specific treatment
Assessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD
Measured: from baseline through study completion, an average of 3 year
clinical and therapeutic data
Assessment of any comorbidities;
Measured: from baseline through study completion, an average of 3 year
characterization of diagnostic criteria
Outlining possible diagnostic criteria specific to AD in adults;
Measured: from baseline through study completion, an average of 3 year
Assessment of possible conditioning factors
Evaluation of the natural history of AD and identification of possible conditioning factors;
Measured: from baseline through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Jun 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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.
- 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
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piergiacomo MD Calzavara Pinton, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313333
- Sponsor's protocol ID
- SID01
- Acronym
- ATOPYREG
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Nazionale Della Dermatite Atopica Moderata e Severa Nell'Adulto
- ClinicalTrials.gov ID
- NCT06313333
- Acronym / sponsor ID
- ATOPYREG / SID01
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente TrasmesseUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Mar 2024 (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.
Collect clinical history and treatment data of AD in adulthood;
Detailed description
Atopic dermatitis is a chronic-recurrent inflammatory skin disease with high prevalence in children and frequently presenting clinical remission during or after childhood; however, it may persist and/or recur, even after long and transient remission, adulthood. In addition, in some adult patients, DA is not present in pediatric age, but onset in adulthood: the investigators speak, in these cases, of adult-onset DA. The prevalence of DA is increasing all over the world and the cases in which clinical manifestations appear or persist during adolescence and/or adulthood are increased especially in industrialized countries. are not currently available specific laboratory markers for diagnosis of DA and, therefore, diagnosis is eminently clinical. In fact, at the present time, there are no validated diagnostic criteria, nor is there a clear consensus on diagnostic-therapeutic pathway to be followed when evaluating patients with adult DA. For these reasons, the collection of data related to various aspects of the DA such as those epidemiological, medical and clinical history, as well as the impact of the disease on the quality of life, results of crucial importance for estimating the real prevalence of this disease in Italy and also, possibly, to outline possible diagnostic criteria specific to adult DA, so that to facilitate and improve the diagnostic-therapeutic path of the patient. The intention of the project, therefore, is to create and use a National Register dedicated to DA patients in adulthood regardless of the period of onset of their pathology. aim to place the Italian Register as a supranational reference for international studies conducted on the adult DA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The nature of the study is descriptive. Each centre undertakes to recruit all adult patients diagnosed with moderate-severe atopic dermatitis observed at the center.
Key inclusion criteria (9 listed)
- Age 18 years
- Signature of informed consent
- Diagnosis of moderate and/or severe DA by a dermatologist specialist defined on the basis of following criteria (10):
Key exclusion criteria (3 listed)
- Patient unable to provide informed consent prior to any collection procedures data on the study;
- unable to complete the procedures required for the study;
- a patient already participating in another follow-up register of the same disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological data
Time frame: from baseline through study completion, an average of 3 year
Reassessment of the epidemiology of AD
Identification of factors for specific treatment
Time frame: from baseline through study completion, an average of 3 year
Assessment of treatment profiles and identification of factors that determine the decision about the specific treatment of moderate and severe AD
clinical and therapeutic data
Time frame: from baseline through study completion, an average of 3 year
Assessment of any comorbidities;
characterization of diagnostic criteria
Time frame: from baseline through study completion, an average of 3 year
Outlining possible diagnostic criteria specific to AD in adults;
Assessment of possible conditioning factors
Time frame: from baseline through study completion, an average of 3 year
Evaluation of the natural history of AD and identification of possible conditioning factors;
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 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Piergiacomo MD Calzavara Pinton principal investigator
Asst Degli Spedali Civili Di Brescia
1 site 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 Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
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 9 inclusion and 3 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Piergiacomo MD Calzavara Pinton (0303995305, piergiacomo.calzavarapinton@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological data (time frame: from baseline through study completion, an average of 3 year). The study lists 5 primary outcomes in all. 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 12 Jun 2025.