A non-interventional, prospective 52-week clinical study investigating improvements in patient-reported outcomes (PROs) in individuals with moderate-to-severe atopic dermatitis (AD) involving the genital region, treated with tralokinumab as part of routine care.

A non-interventional, prospective 52-week clinical study investigating improvements in patient-reported outcomes (PROs) in individuals with moderate-to-severe atopic dermatitis (AD) involving the genital region, treated with tralokinumab as part of routine care. - AD Genital

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038062

Enrollment

Registered

2025-10-08

Start date

2025-10-22

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L20

Interventions

Group 1: A total of 30 patients with moderate-to-severe AD involving the genital region, for whom the clinical decision to initiate treatment with tralokinumab has been made independently of the study

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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: • 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
- Improvement in general PRO instruments [e.g., Patient-Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT), Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depresssion Scale (HADS)] in patients with moderate-to-severe AD undergoing treatment with tralokinumab over a 52-week period. - Improvement in overall disease severity [e.g., Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Investigator Global Assessment (IGA)] in patients with moderate-to-severe AD undergoing treatment with tralokinumab over a 52-week period. - Exploratory assessment of skin changes using non-invasive imaging techniques (OCT, confocal microscopy, or LC-OCT) will be performed, where feasible and acceptable to participants, in patients with moderate-to-severe AD receiving tralokinumab over a 52-week period. Imaging will be conducted at both centers. Image analysis will be carried out at the Department of Dermatology, University Hospital Augsburg (UKA), Augsburg, Germany.	—

Measure

Time frame

- Improvement in general PRO instruments [e.g., Patient-Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT), Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depresssion Scale (HADS)] in patients with moderate-to-severe AD undergoing treatment with tralokinumab over a 52-week period. - Improvement in overall disease severity [e.g., Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Investigator Global Assessment (IGA)] in patients with moderate-to-severe AD undergoing treatment with tralokinumab over a 52-week period. - Exploratory assessment of skin changes using non-invasive imaging techniques (OCT, confocal microscopy, or LC-OCT) will be performed, where feasible and acceptable to participants, in patients with moderate-to-severe AD receiving tralokinumab over a 52-week period. Imaging will be conducted at both centers. Image analysis will be carried out at the Department of Dermatology, University Hospital Augsburg (UKA), Augsburg, Germany.

—

Countries

Germany

Contacts

Public ContactInga Brouer

Institute and Comprehensive Center for Inflammation Medicine (CCIM) of the University Medical Center Schleswig-Holstein (UKSH)

IngaCatharina.Brouer@uksh.de+49451 500 - 41626

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026