Actively Recruiting
Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Led by University Hospital Schleswig-Holstein · Updated on 2026-03-03
30
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University Hospital Schleswig-Holstein
Lead Sponsor
L
LEO Pharma
Collaborating Sponsor
AI-Summary
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)
CONDITIONS
Official Title
Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and communicate with the investigator and comply with study requirements
- Provide written, signed, and dated informed consent before any study activity
- At least 18 years of age at enrollment
- Starting treatment with tralokinumab based on clinical decision independent of the study
- Diagnosed with moderate-to-severe atopic dermatitis involving the genital area and eligible for systemic therapy according to local guidelines
You will not qualify if you...
- Meet exclusion criteria according to licensed tralokinumab specifications
- Unable to give full informed consent
- Currently participating in another study involving investigational products (noninterventional or registries allowed)
- Currently pregnant or nursing
- Do not have genital involvement of atopic dermatitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Dermatology of the University Hospital Augsburg
Augsburg, München, Germany, 86156
Actively Recruiting
2
CCIM, Institut für Entzündungsmedizin UKSH Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
Research Team
I
Inga Brouer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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