About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with moderate-to-severe atopic dermatitis
Trial design
Cohort
Prospective
Treatments tested in this trial
No study intervention
Other intervention
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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