Clinical Trial

Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact

Study acronym: AD Genital
Recruiting
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Summary
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)
Trial Details
NCT Number NCT07444801
Lead Sponsor University Hospital Schleswig-Holstein
Collaborators: LEO Pharma
Conditions Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region
Enrollment 30 participants
Start Date 2025-10-20
Primary Completion 2027-10-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-03