Identification of Biological and Psychosocial Factors of Symptom Persistence in Pruritus

Conditions: L20.8
L29.8
L29.9
Other atopic dermatitis
Other pruritus
Pruritus, unspecified

Registration Number: DRKS00026646

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

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

- 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).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Pruritus Intensity assessed by the numerical rating scale (NRS, worst 24h) <br>• Generic assessment of overall symptom severity using the Patient Health Questionnaire-15 (PHQ-15) and the NRS for symptom intensity

Secondary Outcome Measures

Name	Time	Method
• Pruritus characteristics (intensity, quality, duration, etc) and course (Itch Controlled Days)<br>• Pruritus-related Quality of Life (ItchyQoL) and scratch pleasureness (NRS)<br>• Sensory profile obtained by quantitative sensory testing including alloknesis/hyperknesis <br>• Cutaneous nerve fibre (anatomy, immunohistochemistry)<br>• Molecular marker (PCR, NGF, Sema3A, Artemin)<br>• Pro-inflammatory markers (in blood samples) <br>• Nanostructure of the skin barrier, cellular metabolic alterations of keratinocytes