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

Condition(s) studied

Investigational drug(s) / intervention(s)

tralokinumab: Patients receive tralokinumab as part of routine clinical care according to the licensed product label and physician's clinical decision. The study is observational and does not dictate or assign treatment; it collects data on patients treated with tralokinumab under real-world conditions.

Study 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)

Eligibility

Primary outcome measure(s)

• Genital-Numerical Rating Scale — 52-week period
  Improvement of ≥50% in Genital-Numerical Rating Scale (g-NRS) or ≥2 points in Genital-Investigator Global Assessment (g-IGA) in patients with moderate-to-severe AD treated with tralokinumab over a 52-week period.

Trial sites (2)

More University Hospital Schleswig-Holstein trials in Germany