Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Recruiting · NCT07444801 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital Schleswig-Holstein
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
Inclusion criteria
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
- Subjects must be at least 18 years of age at time of enrollment.
- Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.
- Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label.
Exclusion criteria
- Exclusion criteria will comply with the licensed specifications for tralokinumab.
- Subjects incapable of giving full informed consent.
- Current participation in another study with any investigational products (noninterventional or registries are allowed).
- Currently pregnant or nursing women will be excluded from this study.
- Subjects without genital involvement
Where it is running
2 locations listed.
- Department of Dermatology of the University Hospital Augsburg - Augsburg, München, Germany
- CCIM, Institut für Entzündungsmedizin UKSH Lübeck - Lübeck, Schleswig-Holstein, Germany