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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
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No study intervention | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline oSCORAD at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate-to-severe atopic dermatitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jochen Schmitt, Prof.Dr. | Contact | +493514586493 | jochen.schmitt@uniklinikum-dresden.de | |
| Eva Haufe, Dr. | Contact | +493514586491 | eva.haufe@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Jochen Schmitt, Prof.Dr. | Center for Evidence-based Healthcare, Technical University Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics for Dermatology, Allergy and Venerology, Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
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| Label | URL |
|---|---|
| All Information about the Register-Project | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2021 | May 3, 2022 | Prot_000.pdf |
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| 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. |
| 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. | 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. | 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. | Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years |
| Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
|
| Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
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