L20.9
Conditions
Interventions
Group 1: Patients with atopic dermatitis
Adult patients (=18 years) with a clinically confirmed diagnosis of atopic dermatitis and at least one suitable skin lesion are assessed during a single study
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible participants may include patients of all Fitzpatrick phototypes (I–VI). The Fitzpatrick phototype will be assessed and documented at the time of study inclusion. For the purpose of describing the study population, lighter phototypes are defined as Fitzpatrick I–III and darker phototypes as Fitzpatrick IV–VI. The latter are commonly referred to in the dermatological literature as “skin of color.” An approximately balanced distribution of phototypes, particularly between these groups, will be aimed for in order to enable exploratory comparative analyses. This classification is used exclusively for analytical purposes and does not constitute an inclusion criterion. Inclusion criteria: • Age = 18 years • Clinically confirmed diagnosis of atopic dermatitis • Presence of at least one lesion suitable for tape stripping • Capacity to provide informed consent and written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Acute skin infection in the intended sampling area • Severe excoriations or ulcerations at the sampling site • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The primary endpoint of the study is the one-time detection and quantification of molecular inflammatory signatures in tape-strip samples obtained from hyperpigmented skin lesions of patients with atopic dermatitis in whom there is only minimal or no visible erythematous component on clinical examination. Sample collection is performed during a single study visit by minimally invasive epidermal sampling using tape stripping (10 consecutive strips per sampling site). The endpoint is determined by analysis of epidermal inflammatory markers at the protein and RNA level. Primary hypothesis: Hyperpigmented lesions in patients with higher Fitzpatrick phototypes contain persistent molecular inflammatory signatures in the epidermal tissue, although clinically there is little or no visible erythema. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives To correlate molecular inflammatory markers obtained from tape-strip samples with clinical disease parameters, particularly the EASI score and the erythema subscore. To investigate whether erythema-based clinical scores underestimate inflammatory activity in patients with more strongly pigmented skin. To perform mechanistic analyses of the potential influence of epidermal pigmentation on inflammatory signaling pathways using reconstructed three-dimensional epidermal models under standardized cytokine stimulation (IL-4/IL-13). | — |
Countries
Germany
Contacts
Public ContactJörg Wenzel
Universitätsklinikum Bonn
Outcome results
None listed