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Identification of Biological and Psychosocial Factors of Symptom Persistence in Pruritus

Identification of Biological and Psychosocial Factors of Symptom Persistence in Pruritus - SOMACROSS-Pruritus-4

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026646
Enrollment
200
Registered
2021-09-17
Start date
2021-09-21
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L20.8 L29.8 L29.9

Interventions

Group 1: 40 patients with acute atopic dermatitis. Patients will be followed up for 12 months with three visits (baseline, 6 months, and 12 months). At each visit, there will be a clinical examinati

Sponsors

Kompetenzzentrum Chronischer Pruritus, Klinik für Hautkrankheiten, Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactSabine Hansen

Kompetenzzentrum Chronischer Pruritus, Klinik für Hautkrankheiten, Universitätsklinikum Münster

Sabine.Hansen2@ukmuenster.de0049-(0)152-54957027

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026