Atopic DermatitisNCT05819463
Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland
An observational study of Atopic Dermatitis, run by Swiss Society of Dermatology and Venereology at 9 sites in Switzerland.
Trial summary
As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 700 participants
- Where
- 9 sitesSwitzerland
- Study dates
- 2 Jun 2022to 31 Dec 2032
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study aims at including 700 patients with moderate to severe atopic dermatitis in the registry.
Who may be able to join
- Age ≥ 12 years
- AD according to the UK Working Party's Diagnostic Criteria (28)
- Moderate to severe AD as defined by
- objective SCORAD > 20 or IGA ≥ 3 (moderate) or
- currently on systemic antiinflammatory therapy for AD or
- previous systemic antiinflammatory therapy for AD within past 24 months
Who cannot join
- refusal to sign the informed consent form
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Switzerland9 sites, 9 recruiting
- Recruiting
Universitätsspital Basel, Allergologie
Basel, 4031
Karin Hartmann, Prof. Dr. med., +41 61 265 40 98, allergologie@usb.ch
- Recruiting
Inselspital, Department of Dermatology
Bern, 3010
Dagmar Simon, Prof. Dr. med., +41 31 63 2 22 78, dagmar.simon@insel.ch
- Recruiting
Dermatology & Skin Care Clinic
Buochs, 6374
Ahmad Jalili, PD Dr. Dr. med., +41 41 620 00 60, ahmad.jalili@dsc-clinic.ch
- Recruiting
HFR Hôpital Cantonal de Fribourg
Fribourg, 1752
Basile Page, Dr. med., +41 26 306 22 10, basile.page@h-fr.ch
- Recruiting
Dermatologie CHUV
Lausanne, 1011
Teofila Caplanusi, Dr. med., +41 79 556 47 27, teofila.caplanusi@chuv.ch
- Not yet recruiting
Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie
Lucerne, 6000
Christoph Brand, Prof. Dr. med., +41 41 205 52 25, christoph.brand@luks.ch
- Recruiting
Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie
Sankt Gallen, 9007
Ieva Saulite, Dr. med., +41 71 494 19 29, studien.dermatologie@kssg.ch
- Recruiting
PLAZA Kliniken
Uster, 8610
Tobias Plaza, Dr. med., +41 44 940 49 49, t.plaza@hin.ch
- Recruiting
Institut für Dermatologie und Venerologie Stadtspital Zürich Europaallee
Zurich
Siegfried Borelli, Dr. med., +41 44 416 32 00, praxen.europaallee@stadtspital.ch
About this study
Official title: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.
Read the detailed description
A prospective, non-interventional, national multicenter study in patients with moderate-to-severe AD. According to the availability of approved systemic drugs for the treatment of AD, the study will include children ≥12 years, adolescents and adult patients.
The general goal of the AD registry TREATswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe AD.
The primary objective of the AD registry is the documentation of medical care given to patients with moderate-to-severe AD in order to assess the appropriateness of care.
Further objectives of the AD registry are:
- to evaluate the psychosocial impact of AD;
- to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and
- to establish a research network and foster clinical research projects.
The study procedures include:
- No study related intervention will be performed
- Patients have to fulfill all inclusion criteria to be enrolled in the study.
- Included patients are prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.
- During the observation period, standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, reasons for treatment decisions, and satisfaction with treatment.
- 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.
Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis
assess medical substances given systemically to treat AD
Measured: 24 months
Secondary outcomes (9)
assessment of patients demographic data
assess sex (male, female), age (years)
Measured: 24 months
assessment of past treatment and current treatment
assess specific medical substances (name, dosage, duration of therapy, clinical effects, adverse effects)
Measured: 24 months
assessment of concomitant topical therapy for AD and concomitant treatment
describe medical substances given for AD skin therapy (e.g. topical corticosteroids) and topical calcineurin inhibitors), and medical substances given for concomitant diseases
Measured: 24 months
assessment of past and current comorbidities
describe diseases
Measured: 24 months
change in subjective and objective SCORAD (SCORing Atopic Dermatitis)
outcome measure for disease severity
Measured: 24 months
change in EASI (Eczema Area and Severity Index)
Investigator-assessed outcome measure for disease severity
Measured: 24 months
change in DLQI (Dermatology Life Quality Index)
Patient-reported outcome measure for skin-related quality of life
Measured: 24 months
change in POEM (Patient Oriented Eczema Measure)
Patient-reported outcome measure for atopic eczema severity
Measured: 24 months
change in RECAP (Recap of atopic eczema)
Patient-reported outcome measure to capture eczema control
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start2 Jun 2022
- Primary completionMay 2032 (estimated)
- Study completion31 Dec 2032 (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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Society of Dermatology and Venereology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dagmar Simon, Prof. Dr. med., Principal investigator, Department of Dermatology, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819463
- Sponsor's protocol ID
- 2022-00205
- Status last verified
- Apr 2025
- First submitted
- 23 Jan 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
- ClinicalTrials.gov ID
- NCT05819463
- Acronym / sponsor ID
- 2022-00205
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Swiss Society of Dermatology and VenereologyUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 19 Apr 2023 (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.
As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.
Detailed description
A prospective, non-interventional, national multicenter study in patients with moderate-to-severe AD. According to the availability of approved systemic drugs for the treatment of AD, the study will include children ≥12 years, adolescents and adult patients.
The general goal of the AD registry TREATswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe AD.
The primary objective of the AD registry is the documentation of medical care given to patients with moderate-to-severe AD in order to assess the appropriateness of care.
Further objectives of the AD registry are:
- to evaluate the psychosocial impact of AD;
- to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and
- to establish a research network and foster clinical research projects.
The study procedures include:
- No study related intervention will be performed
- Patients have to fulfill all inclusion criteria to be enrolled in the study.
- Included patients are prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.
- During the observation period, standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, reasons for treatment decisions, and satisfaction with treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study aims at including 700 patients with moderate to severe atopic dermatitis in the registry.
Key inclusion criteria (6 listed)
- Age ≥ 12 years
- AD according to the UK Working Party's Diagnostic Criteria (28)
- Moderate to severe AD as defined by
- objective SCORAD > 20 or IGA ≥ 3 (moderate) or
- currently on systemic antiinflammatory therapy for AD or
Key exclusion criteria (1 listed)
- refusal to sign the informed consent form
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
Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis
Time frame: 24 months
assess medical substances given systemically to treat AD
9 secondary outcomes
assessment of patients demographic data
Time frame: 24 months
assessment of past treatment and current treatment
Time frame: 24 months
assessment of concomitant topical therapy for AD and concomitant treatment
Time frame: 24 months
assessment of past and current comorbidities
Time frame: 24 months
change in subjective and objective SCORAD (SCORing Atopic Dermatitis)
Time frame: 24 months
change in EASI (Eczema Area and Severity Index)
Time frame: 24 months
change in DLQI (Dermatology Life Quality Index)
Time frame: 24 months
change in POEM (Patient Oriented Eczema Measure)
Time frame: 24 months
change in RECAP (Recap of atopic eczema)
Time frame: 24 months
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 30 Apr 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.
Dagmar Simon, Prof. Dr. med. principal investigator
Department of Dermatology, Inselspital
9 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 Swiss Society of Dermatology and Venereology at 9 sites in Switzerland.
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 6 inclusion and 1 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Switzerland. 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 Dagmar Simon, Prof. Dr. med. (+41 31 632 22 78, dagmar.simon@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis (time frame: 24 months). 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 30 Apr 2025.