Atopic DermatitisADBest-TREATNCT07904546
ADBest TREAT Registry
An observational study of Atopic Dermatitis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Atopic dermatitis is a chronic inflammatory skin disease associated with intense pruritus, recurrent eczematous lesions, sleep disturbance, and reduced quality of life. The disease may be influenced by genetic factors, environmental triggers, epidermal barrier dysfunction, and immune dysregulation. 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?
- Abrocitinib, Baricitinib and Upadacitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2032
- How long will I take part?
- 5 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: Study population description:Patients with atopic dermatitis treated in participating dermatology centers and entered in to ADBest-TREAT registry.
Who may be able to join
- Age >18 years
- Planned initiation of systemic therapy
- Clinically confirmed diagnosis of atopic dermatitis
- Written informed consent after patient education
Who cannot join
- Patient who do not provide written informed consent
- Patients Younger than 18 years
- Patients without a clinically confirmed diagnosis of atopic dermatitis
- Patients for whom systemic therapy is not planned
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institute for Health Services Research in Dermatology and Nursing, IVDP; University Medical Center Hamburg-Eppendorf,UKE
Hamburg, 20246
Matthias Augustin, Prof.Dr., +4940741055428, m.augustin@uke.de
About this study
Official title: ADBest-TREAT: A Registry for Patients With Atopic Dermatitis Receiving Systemic, Local, or UV Therapy
Atopic dermatitis is a chronic inflammatory skin disease associated with intense pruritus, recurrent eczematous lesions, sleep disturbance, and reduced quality of life. The disease may be influenced by genetic factors, environmental triggers, epidermal barrier dysfunction, and immune dysregulation. Patients may experience flares triggered by allergens, infections, dry skin, stress, irritants, or other environmental factors. Atopic dermatitis can also be associated with secondary bacterial or viral skin infections and a substantial burden on daily activities, work productivity, sleep, and psychosocial well-being.TREAT is the German national treatment registry for patients with atopic dermatitis. The registry collects real-world data from routine dermatological care to assess disease course, treatment patterns, disease burden, patient-relevant treatment benefits, and quality of life. Data are collected electronically using physician-completed eCRFs and patient-completed questionnaires at inclusion and follow-up visits. The registry aims to improve understanding of atopic dermatitis real-world care and outcomes in daily clinical practice.
Read the detailed description
ADBest-TREAT uses a fully electronic data collection system. Study data are collected through web-based electronic case report forms (eCRFs), which can be completed via a web browser on a computer or tablet. After a patient is included in the registry, the patient is registered in the eCRF system using a pseudonymized identification number, and a visit schedule is generated automatically.
The registry uses separate electronic forms for physicians and patients. Physicians complete online doctor eCRFs at the inclusion visit and follow-up visits. These physician-completed eCRFs document eligibility criteria, clinical diagnosis, disease course, clinical phenotype, affected body sites, disease severity scores including PGA/IGA and EASI (Eczema Area and Severity Index), comorbidities, allergic sensitization, previous and current therapies, treatment changes, safety and tolerability information, and planned follow-up.
Patients complete separate online patient questionnaires and/or patient app entries during routine visits at defined intervals. These patient-completed questionnaires collect patient-reported information, including demographic data, lifestyle factors, disease history, family history of atopic diseases, symptoms, flares, physician visits, work impairment, affected skin areas, itch, sleep impairment, pain, dermatology-related quality of life using the DLQI (Dermatology Life Quality Index), treatment satisfaction, treatment benefit, and the personal importance of treatment goals.
Physician-reported and patient-reported data are therefore collected separately but within the same electronic registry system, allowing clinical information from physicians and patient-reported outcomes from patients to be analyzed together.
- Conditions
- Atopic Dermatitis
- Being tested
- Abrocitinib, Baricitinib, Upadacitinib, Dupilumab, Lebrikizumab
- Keywords
- Atopic dermatit, eczema, chronic inflammatory skin disease, real-world evidence
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Oral JAK1 inhibitor administered fot the treatment of atopic dermatitis.
BaricitinibDrug
Oral JAK1 inhibitor administered for the treatment of atopic dermatitis.
UpadacitinibDrug
Oral JAK1 inhibitor administered for the treatment of atopic dermatitis.
DupilumabBiological
Monaclonal antibody targeting IL4 and IL-13 receptors fot the treatment of moderate to severe atopic dermatitis.
LebrikizumabBiological
Monaclonal antibody targeting IL-13 receptors fot the treatment of moderate to severe atopic dermatitis.
NemolizumabBiological
Monoclonal antibody targeting IL31 receptor alpha to inhibit pruritus and inflammation in atopic dermatitis.
TralokinumabBiological
Monoclonal antibody neutralizing IL13 specifically for the treatment of atopic dermatitis.
Conventional Systemic TherapyOther
Conventional systemic treatments including traditional immunosuppressants or corticosteroids administrated for moderate to severe atopic dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| JAK Inhibitor Therapy | Patients with atopic dermatitis treated with JAK inhibitors, including abrocitinib, baricitinib, and upadacitinib Receives: Drug: Abrocitinib; Drug: Baricitinib; Drug: Upadacitinib | |
| Biologic Therapy | Patients with atopic dermatitis treated with biologic therapies, including dupilumab, lebrikizumab, nemolizumab, and tralokinumab. Receives: Biological: Dupilumab; Biological: Lebrikizumab; Biological: Nemolizumab; Biological: Tralokinumab | |
| Other Systemic Therapy | Patients with atopic dermatitis receiving systemic treatments other than biologicals and JAK-inhibitors. Receives: Other: Conventional Systemic Therapy | |
| Local Therapy / UV Therapy | Patients with atopic dermatitis receiving topical treatment and/or ultraviolet therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index(EASI) score
Atopic dermatititis severity will be assessed by the physician using the Eczema Area and Severity Index (EASI).The score ranges from 0 to 72 ,with higher scores indicating greater disease severity.
Measured: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months.
Dermatology Life Quality Index (DLQI) score
Quality of life will be assessed using the 10 -item Dermatology Life Quality Index.(DLQ),referring to the previous week.Total score ranges from 0 to 30 ;Higher scores indicates greater impairement of quality of life.
Measured: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months;an additional visit during weeks 0-4 may occur optionally.
Secondary outcomes (9)
Physician-reported clinical phenotype and affected body sites
Clinical phenotype and affected body sites are documented by the physician using the online eCRF, including disease course, clinical subtype, and current eczematous involvement of predefined anatomical areas.
Measured: At inclusion;phenotype and disease course updated as needed.Body -site involvement assessed at registry inclusion (week 0) at weeks 16,28,and 52 ,then every 24 weeks through months 60.
Atopic Dermatitis-related Pain Intensity
Pain intensity during 24 hours,rated by the patient on a 0-10 scale (0=no pain;10=worst imaginable pain).Higher scores indicate more pain.
Measured: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Physician-reported Adverse Events During Routine Care
Adverse events are documented by treating physicians in the online electronic case report form (eCRF) during routine care. Results will be reported as the number and percentage of participants with at least one documented adverse event;event type and severity will be reported when available.
Measured: At weeks 16,28, and 52, then every 24 weeks through month 60,and at unscheduled visits when applicable.
Physician/Investigator Global Assessment( PGA/IGA).
Atopic dermatitis severity is assessed by the physician using the Physician /Investigator Global Assessment (PGA/IGA).Scores range from 0 to 5 :0=clear,1=almost clear,2=mild,3=moderate,4=severe, and 5 =very severe.Higher scores indicate greater disease severity.
Measured: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Sleep impairment
Atopic dermatitis-related sleep impairment during the previous night,rated by the patient on a 0-10 scale (0=no impairment;10=extreme impairment).Higher scores indicate greater impairment.
Measured: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient-assessed atopic dermatitis severity
Current disease severity reported by the patient as clear,almost clear,mild,moderate ,severe,or very severe.
Measured: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient-reported disease control
Number of weeks during the previous 12 weeks in which atopic dermatitits was well controlled,reported by the patient(0-12 weeks).
Measured: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient satisfaction with treatment
Patient satisfaction with medical care and atopic dermatitis treatment during the previous 3 months,rated on a 0-10 scale(0=very dissatisfied,10=very satisfied).
Measured: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Atopic Dermatitis-related Itch Intensity
Patient-reported worst itch intensity due to atopic dermatitis during the previous 24 hours,measured on an 11-point numeric rating scale from 0(no itch) to 10 (worst imaginable itch).Higher scores indicate greater itch intensity.
Measured: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jan 2023
- Primary completion31 Dec 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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904546
- Sponsor's protocol ID
- 2022-100895-BO
- Acronym
- ADBest-TREAT
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not publicly shared
Publications
Muller D, Augustin M, Banik N, Baumann W, Bestehorn K, Kieschke J, Lefering R, Maier B, Mathis S, Rustenbach SJ, Sauerland S, Semler SC, Stausberg J, Sturm H, Unger C, Neugebauer EA. [Memorandum registry for health services research]. Gesundheitswesen. 2010 Nov;72(11):824-39. doi: 10.1055/s-0030-1263132. Epub 2010 Sep 24. German.
PubMed 20872343Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/
PubMed 24945055S3-Leitlinie "Atopische Dermatitis" (AWMF-Register. 013-027). 2023.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADBest-TREAT: A Registry for Patients With Atopic Dermatitis Receiving Systemic, Local, or UV Therapy
- ClinicalTrials.gov ID
- NCT07904546
- Acronym / sponsor ID
- ADBest-TREAT / 2022-100895-BO
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatit, eczema, chronic inflammatory skin disease, real-world evidence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 29 Oct 2026 (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 chronic inflammatory skin disease associated with intense pruritus, recurrent eczematous lesions, sleep disturbance, and reduced quality of life. The disease may be influenced by genetic factors, environmental triggers, epidermal barrier dysfunction, and immune dysregulation. Patients may experience flares triggered by allergens, infections, dry skin, stress, irritants, or other environmental factors. Atopic dermatitis can also be associated with secondary bacterial or viral skin infections and a substantial burden on daily activities, work productivity, sleep, and psychosocial well-being.TREAT is the German national treatment registry for patients with atopic dermatitis. The registry collects real-world data from routine dermatological care to assess disease course, treatment patterns, disease burden, patient-relevant treatment benefits, and quality of life. Data are collected electronically using physician-completed eCRFs and patient-completed questionnaires at inclusion and follow-up visits. The registry aims to improve understanding of atopic dermatitis real-world care and outcomes in daily clinical practice.
Detailed description
ADBest-TREAT uses a fully electronic data collection system. Study data are collected through web-based electronic case report forms (eCRFs), which can be completed via a web browser on a computer or tablet. After a patient is included in the registry, the patient is registered in the eCRF system using a pseudonymized identification number, and a visit schedule is generated automatically.
The registry uses separate electronic forms for physicians and patients. Physicians complete online doctor eCRFs at the inclusion visit and follow-up visits. These physician-completed eCRFs document eligibility criteria, clinical diagnosis, disease course, clinical phenotype, affected body sites, disease severity scores including PGA/IGA and EASI (Eczema Area and Severity Index), comorbidities, allergic sensitization, previous and current therapies, treatment changes, safety and tolerability information, and planned follow-up.
Patients complete separate online patient questionnaires and/or patient app entries during routine visits at defined intervals. These patient-completed questionnaires collect patient-reported information, including demographic data, lifestyle factors, disease history, family history of atopic diseases, symptoms, flares, physician visits, work impairment, affected skin areas, itch, sleep impairment, pain, dermatology-related quality of life using the DLQI (Dermatology Life Quality Index), treatment satisfaction, treatment benefit, and the personal importance of treatment goals.
Physician-reported and patient-reported data are therefore collected separately but within the same electronic registry system, allowing clinical information from physicians and patient-reported outcomes from patients to be analyzed together.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JAK Inhibitor Therapy | – | Drug: Abrocitinib, Drug: Baricitinib, Drug: UpadacitinibPatients with atopic dermatitis treated with JAK inhibitors, including abrocitinib, baricitinib, and upadacitinib |
| Biologic Therapy | – | Biological: Dupilumab, Biological: Lebrikizumab, Biological: Nemolizumab, Biological: TralokinumabPatients with atopic dermatitis treated with biologic therapies, including dupilumab, lebrikizumab, nemolizumab, and tralokinumab. |
| Other Systemic Therapy | – | Other: Conventional Systemic TherapyPatients with atopic dermatitis receiving systemic treatments other than biologicals and JAK-inhibitors. |
| Local Therapy / UV Therapy | – | –Patients with atopic dermatitis receiving topical treatment and/or ultraviolet therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population description:Patients with atopic dermatitis treated in participating dermatology centers and entered in to ADBest-TREAT registry.
Key inclusion criteria (4 listed)
- Age >18 years
- Planned initiation of systemic therapy
- Clinically confirmed diagnosis of atopic dermatitis
- Written informed consent after patient education
Key exclusion criteria (4 listed)
- Patient who do not provide written informed consent
- Patients Younger than 18 years
- Patients without a clinically confirmed diagnosis of atopic dermatitis
- Patients for whom systemic therapy is not planned
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 |
|---|---|---|
| AbrocitinibOral JAK1 inhibitor administered fot the treatment of atopic dermatitis. | Drug | JAK Inhibitor Therapy |
| BaricitinibOral JAK1 inhibitor administered for the treatment of atopic dermatitis. | Drug | JAK Inhibitor Therapy |
| UpadacitinibOral JAK1 inhibitor administered for the treatment of atopic dermatitis. | Drug | JAK Inhibitor Therapy |
| DupilumabMonaclonal antibody targeting IL4 and IL-13 receptors fot the treatment of moderate to severe atopic dermatitis. | Biological | Biologic Therapy |
| LebrikizumabMonaclonal antibody targeting IL-13 receptors fot the treatment of moderate to severe atopic dermatitis. | Biological | Biologic Therapy |
| NemolizumabMonoclonal antibody targeting IL31 receptor alpha to inhibit pruritus and inflammation in atopic dermatitis. | Biological | Biologic Therapy |
| TralokinumabMonoclonal antibody neutralizing IL13 specifically for the treatment of atopic dermatitis. | Biological | Biologic Therapy |
| Conventional Systemic TherapyConventional systemic treatments including traditional immunosuppressants or corticosteroids administrated for moderate to severe atopic dermatitis. | Other | Other Systemic Therapy |
Primary outcome
Eczema Area and Severity Index(EASI) score
Time frame: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months.
Atopic dermatititis severity will be assessed by the physician using the Eczema Area and Severity Index (EASI).The score ranges from 0 to 72 ,with higher scores indicating greater disease severity.
Dermatology Life Quality Index (DLQI) score
Time frame: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months;an additional visit during weeks 0-4 may occur optionally.
Quality of life will be assessed using the 10 -item Dermatology Life Quality Index.(DLQ),referring to the previous week.Total score ranges from 0 to 30 ;Higher scores indicates greater impairement of quality of life.
9 secondary outcomes
Physician-reported clinical phenotype and affected body sites
Time frame: At inclusion;phenotype and disease course updated as needed.Body -site involvement assessed at registry inclusion (week 0) at weeks 16,28,and 52 ,then every 24 weeks through months 60.
Atopic Dermatitis-related Pain Intensity
Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Physician-reported Adverse Events During Routine Care
Time frame: At weeks 16,28, and 52, then every 24 weeks through month 60,and at unscheduled visits when applicable.
Physician/Investigator Global Assessment( PGA/IGA).
Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Sleep impairment
Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient-assessed atopic dermatitis severity
Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient-reported disease control
Time frame: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Patient satisfaction with treatment
Time frame: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
Atopic Dermatitis-related Itch Intensity
Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.
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 29 Oct 2026.
- Background: PubMed 20872343Muller D, Augustin M, Banik N, Baumann W, Bestehorn K, Kieschke J, Lefering R, Maier B, Mathis S, Rustenbach SJ, Sauerland S, Semler SC, Stausberg J, Sturm H, Unger C, Neugebauer EA. [Memorandum registry for health services research]. Gesundheitswesen. 2010 Nov;72(11):824-39. doi: 10.1055/s-0030-1263132. Epub 2010 Sep 24. German.
- Background: PubMed 24945055Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/
- BackgroundS3-Leitlinie "Atopische Dermatitis" (AWMF-Register. 013-027). 2023.
- Individual participant dataSharing planned: No. Individual participant data will not publicly shared
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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.
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 Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 4 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 29 Oct 2026. 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 Germany. 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 Matthias Augustin, Prof.Dr. (+4940741055428, m.augustin@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index(EASI) score (time frame: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07904546, which also lists 3 linked publications.
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 29 Oct 2026.