Chronic Hand Eczema
Conditions
Brief summary
Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with ≥ 2-point improvement in IGA for patients with chronic hand eczema at week 16
Detailed description
Participant self-assessment (PSA) [Time Frame: Baseline, week 2, 4, 6, 8, 12 and 16], Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [Time Frame: Baseline; Week 4, 8, 16], Hand eczema severity index (HECSI) [Time Frame: Baseline; Week 4, 8, 16], Evaluation of safety in terms of number of AE and lab parameters, Change in skin physiology from baseline to week 16, Change in histology, in expression of skin barrier proteins, expression of cytokines, in extent of immune cells in skin biopsies, and the transcriptome from baseline to week 16
Interventions
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic efficacy of deucravacitinib defined as the percentage of patients achieving a clinical response (Investigator Global Assessment 0 or 1) with ≥ 2-point improvement in IGA for patients with chronic hand eczema at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant self-assessment (PSA) [Time Frame: Baseline, week 2, 4, 6, 8, 12 and 16], Quality of Life in Hand Eczema Questionnaire (QOLHEQ) [Time Frame: Baseline; Week 4, 8, 16], Hand eczema severity index (HECSI) [Time Frame: Baseline; Week 4, 8, 16], Evaluation of safety in terms of number of AE and lab parameters, Change in skin physiology from baseline to week 16, Change in histology, in expression of skin barrier proteins, expression of cytokines, in extent of immune cells in skin biopsies, and the transcriptome from baseline to week 16 | — |
Countries
Germany
Outcome results
None listed