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RecruitingNCT07904546ADBest-TREATUpdated Oct 29, 2026

ADBest TREAT Registry

An observational study in Atopic Dermatitis, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic dermatit
  • eczema
  • chronic inflammatory skin disease
  • real-world evidence
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population description:Patients with atopic dermatitis treated in participating dermatology centers and entered in to ADBest-TREAT registry.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18 years
  • Planned initiation of systemic therapy
  • Clinically confirmed diagnosis of atopic dermatitis
  • Written after patient education

Exclusion criteria

Exclusion Criteria:

  • Patient who do not provide written
  • Patients Younger than 18 years
  • Patients without a clinically confirmed diagnosis of atopic dermatitis
  • Patients for whom systemic therapy is not planned
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • JAK Inhibitor Therapy

    Patients with atopic dermatitis treated with JAK inhibitors, including abrocitinib, baricitinib, and upadacitinib

    Drug: Abrocitinib · Drug: Baricitinib · Drug: Upadacitinib

  • Biologic Therapy

    Patients with atopic dermatitis treated with biologic therapies, including dupilumab, lebrikizumab, nemolizumab, and tralokinumab.

    Biological: Dupilumab · Biological: Lebrikizumab · Biological: Nemolizumab · Biological: Tralokinumab

  • Other Systemic Therapy

    Patients with atopic dermatitis receiving systemic treatments other than biologicals and JAK-inhibitors.

    Other: Conventional Systemic Therapy

  • Local Therapy / UV Therapy

    Patients with atopic dermatitis receiving topical treatment and/or ultraviolet therapy.

Interventions

  • Oral JAK1 inhibitor administered fot the treatment of atopic dermatitis.

  • Oral JAK1 inhibitor administered for the treatment of atopic dermatitis.

  • Oral JAK1 inhibitor administered for the treatment of atopic dermatitis.

  • BiologicalDupilumab

    Monaclonal antibody targeting IL4 and IL-13 receptors fot the treatment of moderate to severe atopic dermatitis.

  • BiologicalLebrikizumab

    Monaclonal antibody targeting IL-13 receptors fot the treatment of moderate to severe atopic dermatitis.

  • BiologicalNemolizumab

    Monoclonal antibody targeting IL31 receptor alpha to inhibit pruritus and inflammation in atopic dermatitis.

  • BiologicalTralokinumab

    Monoclonal antibody neutralizing IL13 specifically for the treatment of atopic dermatitis.

  • OtherConventional Systemic Therapy

    Conventional systemic treatments including traditional immunosuppressants or corticosteroids administrated for moderate to severe atopic dermatitis.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At registry inclusion (week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through 60 months.

  2. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  3. 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.

    Time frame: At weeks 16,28, and 52, then every 24 weeks through month 60,and at unscheduled visits when applicable.

  4. 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.

    Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  5. 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.

    Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  6. Patient-assessed atopic dermatitis severity

    Current disease severity reported by the patient as clear,almost clear,mild,moderate ,severe,or very severe.

    Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  7. 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).

    Time frame: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  8. 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).

    Time frame: At weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

  9. 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.

    Time frame: At registry inclusion(week 0),at weeks 16,28, and 52 ,and every 24 weeks thereafter through month 60.

07

Study locations

1 of 1 sites recruiting
  • Institute for Health Services Research in Dermatology and Nursing, IVDP; University Medical Center Hamburg-Eppendorf,UKE
    Hamburg, 20246, Germany
    Recruiting
08

References and documents

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 20872343 ↗
  • Gliklich 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 24945055 ↗
  • S3-Leitlinie "Atopische Dermatitis" (AWMF-Register. 013-027). 2023.

Individual participant data

Plan to share: No — Individual participant data will not publicly shared

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904546
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Jan 1, 2023
Primary completion
Dec 31, 2032 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Oct 29, 2026

Study contacts

Matthias Augustin, Prof.Dr.
Contact
m.augustin@uke.de
+4940741055428

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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