Moderate-to-severe Atopic DermatitisTREATgermanyNCT03057860
TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
An observational study of Moderate-to-severe Atopic Dermatitis, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence. Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moderate-to-severe Atopic Dermatitis
- What is being tested?
- No study intervention
- How many people
- 2,800 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Feb 2016to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with moderate-to-severe atopic dermatitis
Who may be able to join
- AD according to the United Kingdom (UK) working party diagnostic criteria
- Moderate to severe AD
- Objective SCORAD > 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
Dresden, Saxony, 01307
Susanne Abraham, Dr.
Susanne Abraham, Dr.
- Recruiting
Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
Hanover, Lower Saxony, 30625
Thomas Werfel, Prof.
- Recruiting
Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Stephan Weidinger, Prof.
About this study
Official title: TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.
Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.
Read more
Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).
Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).
Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.
In this situation, clinical registries can provide valuable information for evidence-based clinical decision making.
Extension of TREATgermany to children and adolescents is necessary as
- moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood
- it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone
- innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria
- adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group
- Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care
Read the detailed description
Study procedures:
No study related intervention will be performed. Included patients will be 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, physician's reasons for treatment decisions, and satisfaction with treatment.
The first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new systemic treatment was initiated) or after 6 months (in case no new systemic treatment was prescribed).
In a subset of patients biosamples for molecular analyses including blood, swabs and stool will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after systemic therapy initiation. This optional module requires separate patient information and informed consent.
Data assessment:
Prospective electronic documentation of disease course and severity, medical care and pharmaceutical treatment of AD.
Pseudomized data will be stored at the registry center (Center for Evidence-based Healthcare, Dresden).
Study assessments include:
- A short physician report form to document patient history and clinical parameters such as the objective severity of clinical signs, affected body regions, physician's global assessment of disease severity, course of disease and medical treatment of AD including adverse events.
- A patient report form to assess important subjective parameters, patient reported outcomes such as symptoms, quality of life, treatment satisfaction, patient's assessment of global disease severity, totally/partial well-controlled weeks.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- No study intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Atopic Dermatitis (oSCORAD)
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31
Measured: Change from Baseline oSCORAD at 2 years
Secondary outcomes (5)
Patient Oriented Eczema Measure (POEM)
Charman CR, Venn AJ, Williams HC: The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol 2004;140:1513-1519.
Measured: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Severity of Pruritus and Sleeping Problems (VAS)
Charman CR, Venn AJ, Williams HC: The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol 2004;140:1513-1519.
Measured: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Flares (totally/well controlled weeks)
Schmitt J, Langan S, Deckert S, Svensson A, von KL, Thomas K, Spuls P: Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation. J Allergy Clin Immunol 2013;10.
Measured: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Health-related Quality of Life (DLQI)
Finlay AY, Khan GK: Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19:210-216.
Measured: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Eczema Area and Severity Index (EASI)
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M: The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol 2001;10:11-18.
Measured: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Feb 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- 2,800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Schmitt, Prof.Dr., Principal investigator, Center for Evidence-based Healthcare, Technical University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057860
- Sponsor's protocol ID
- EK-118032016
- Acronym
- TREATgermany
- Status last verified
- May 2022
- First submitted
- 7 Feb 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03057860
- Acronym / sponsor ID
- TREATgermany / EK-118032016
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2017 (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.
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.
Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.
Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).
Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).
Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.
In this situation, clinical registries can provide valuable information for evidence-based clinical decision making.
Extension of TREATgermany to children and adolescents is necessary as
- moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood
- it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone
- innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria
- adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group
- Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care
Detailed description
Study procedures:
No study related intervention will be performed. Included patients will be 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, physician's reasons for treatment decisions, and satisfaction with treatment.
The first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new systemic treatment was initiated) or after 6 months (in case no new systemic treatment was prescribed).
In a subset of patients biosamples for molecular analyses including blood, swabs and stool will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after systemic therapy initiation. This optional module requires separate patient information and informed consent.
Data assessment:
Prospective electronic documentation of disease course and severity, medical care and pharmaceutical treatment of AD.
Pseudomized data will be stored at the registry center (Center for Evidence-based Healthcare, Dresden).
Study assessments include:
- A short physician report form to document patient history and clinical parameters such as the objective severity of clinical signs, affected body regions, physician's global assessment of disease severity, course of disease and medical treatment of AD including adverse events.
- A patient report form to assess important subjective parameters, patient reported outcomes such as symptoms, quality of life, treatment satisfaction, patient's assessment of global disease severity, totally/partial well-controlled weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with moderate-to-severe atopic dermatitis
Key inclusion criteria (3 listed)
- AD according to the United Kingdom (UK) working party diagnostic criteria
- Moderate to severe AD
- Objective SCORAD > 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No study intervention | Other | – |
Primary outcome
Score of Atopic Dermatitis (oSCORAD)
Time frame: Change from Baseline oSCORAD at 2 years
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31
5 secondary outcomes
Patient Oriented Eczema Measure (POEM)
Time frame: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Severity of Pruritus and Sleeping Problems (VAS)
Time frame: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Flares (totally/well controlled weeks)
Time frame: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Health-related Quality of Life (DLQI)
Time frame: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Eczema Area and Severity Index (EASI)
Time frame: Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
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 9 May 2022.
- All Information about the Register-ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jochen Schmitt, Prof.Dr. principal investigator
Center for Evidence-based Healthcare, Technical University Dresden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Atopic Dermatitis, run by Technische Universität Dresden at 3 sites 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 3 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Jochen Schmitt, Prof.Dr. (+493514586493, jochen.schmitt@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Atopic Dermatitis (oSCORAD) (time frame: Change from Baseline oSCORAD at 2 years). 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 9 May 2022.