Brief 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)

Conditions

• Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region

Intervention / Treatment

• Drug: tralokinumab

Primary Outcome Measures

• 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.

Countries

Germany

Locations and Investigators

• Department of Dermatology of the University Hospital Augsburg, Augsburg, Germany (Recruiting)
  • Andreas Prof. Wollenberg, Prof.
• CCIM, Institut für Entzündungsmedizin UKSH Lübeck, Lübeck, Germany (Recruiting)
  • Diamant Prof. Thaci, Prof.
  • Prof. Diamant Thaci, Prof. (Principal Investigator)