NCT07444801 Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
| NCT ID | NCT07444801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Schleswig-Holstein |
| Condition | Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-10-20 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07444801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07444801 currently recruiting?
Yes, NCT07444801 is actively recruiting participants. Contact the research team at IngaCatharina.Brouer@uksh.de for enrollment information.
Where is the NCT07444801 trial being conducted?
This trial is being conducted at Augsburg, Germany, Lübeck, Germany.
Who is sponsoring the NCT07444801 clinical trial?
NCT07444801 is sponsored by University Hospital Schleswig-Holstein. The trial plans to enroll 30 participants.
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