NCT07444801Recruiting
Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 2 Oct 2025
- Start date
- 20 Oct 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University Hospital Schleswig-Holstein
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07444801
What you commit to
- Study type: Observational
- Planned participants: 30
- From 20 Oct 2025 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current participation in another study with any investigational products (noninterventional or registries are allowed).
Other
- Exclusion criteria will comply with the licensed specifications for tralokinumab.
- Subjects incapable of giving full informed consent.
- Currently pregnant or nursing women will be excluded from this study.
- Subjects without genital involvement
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Dermatology of the University Hospital Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| CCIM, Institut für Entzündungsmedizin UKSH Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.