Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients (≥18 years) diagnosed with moderate-to-severe atopic dermatitis involving the genital region, who are eligible for systemic therapy with tralokinumab according to the local approved label. Patients are recruited from routine clinical practice at two academic centers and must have signed informed consent prior to any study-related activity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
tralokinumab
DrugPatients 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with moderate-to-severe atopic dermatitis involving the genital region treated with traloki1 intervention
Trial outcomes
Primary outcomes
1
Genital-Numerical Rating Scale
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.
Time frame
52-week periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Schleswig-Holstein
Lead sponsor
LEO Pharma
Collaborator
Source ClinicalTrials.gov