Condition: Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region · Sponsor: University Hospital Schleswig-Holstein
Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)
This description comes directly from the study's public registry record.
Inga Brouer · +4945150041626 · IngaCatharina.Brouer@uksh.de
Always discuss trial participation with your own doctor first.
| Department of Dermatology of the University Hospital Augsburg | Augsburg, München, Germany | Recruiting |
| CCIM, Institut für Entzündungsmedizin UKSH Lübeck | Lübeck, Schleswig-Holstein, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07444801