L20.8 L29.8 L29.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years Group 1: Acute atopic dermatits (aAD) • acute eczema = 4 weeks at baseline • previous eczema free interval for at least 6 months • pruritus intensity (NRS worst pruritus of the last 24h): =5/10 Group 2: chronic atopic dermatitis (cAD) • clinical diagnosis of atopic dermatitis, for at least 6 months • chronic pruritus (= 6 weeks duration) • pruritus intensity (NRS worst pruritus of the last 24h): =5/10 Group 3: chronic pruritus on non-lesional skin (CPNL) • pruritus on non-lesional skin (absence of a dermatosis or scratch lesions) • chronic pruritus (= 6 weeks duration) • pruritus intensity (NRS worst pruritus of the last 24h): =5/10 Group 4: healthy controls • non-lesional skin (absence of a dermatosis or scratch lesions) • no pruritus (pruritus intensity NRS worst pruritus of the last 24h: 0/10) • no history of atopic dermatitis, allergic asthma, type 1 allergies • no chronic pain syndrome or intake of analgesic drugs
Exclusion criteria
Exclusion criteria: - Acute exacerbation of a dermatosis (exception: atopic dermatitis) or cutaneous infection - pregnancy, breastfeeding - drug or alcohol abuse - allergy against local anesthetics - Tendency of developing keloids - Chronic pain, fibromyalgia - Intake of antihistamines, systemic steroids, systemic immunosuppressants, gabapentinoids or analgesics in the previous 4 weeks (intake of antidepressants is allowed if not as antipruritic medication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Pruritus Intensity assessed by the numerical rating scale (NRS, worst 24h) • Generic assessment of overall symptom severity using the Patient Health Questionnaire-15 (PHQ-15) and the NRS for symptom intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| • Pruritus characteristics (intensity, quality, duration, etc) and course (Itch Controlled Days) • Pruritus-related Quality of Life (ItchyQoL) and scratch pleasureness (NRS) • Sensory profile obtained by quantitative sensory testing including alloknesis/hyperknesis • Cutaneous nerve fibre (anatomy, immunohistochemistry) • Molecular marker (PCR, NGF, Sema3A, Artemin) • Pro-inflammatory markers (in blood samples) • Nanostructure of the skin barrier, cellular metabolic alterations of keratinocytes | — |
Countries
Germany
Contacts
Kompetenzzentrum Chronischer Pruritus, Klinik für Hautkrankheiten, Universitätsklinikum Münster