Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07568665

Acronym

ADUTERCoM

Enrollment

Registered

2026-05-06

Start date

2025-11-27

Completion date

2028-11-01

Last updated

2026-09-03

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

Conditions

Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)

Keywords

atopic dermatis, Reflectance Confocal Microscopy, tralokinumab

Brief summary

Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Tralokinumab is a fully human anti-IL-13 monoclonal antibody that has proven to be effective and well-tolerated for the treatment of patients with moderate-to-severe AD. Reflectance confocal microscopy (RCM) is a noninvasive procedure that allows to evaluate epidermis and papillary dermis at a cellular level. RCM allows skin structural and inflammatory parameters evaluation. The aim of this study is to evaluate by RCM skin modifications of AD patients treated with tralokinumab.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years and older. * Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab in the investigator's opinion. * Patients affiliated with or entitled to a social security scheme. * Patients capable of giving informed consent. * Patients who have received informed information about the study and have co-signed an informed consent form for participation in the study, along with the investigator.

Exclusion criteria

* Patients who refuse to participate in the study and legally incapacitated adults * Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment. * Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.

Design outcomes

Primary

Measure	Time frame	Description
Thickness of the atopic skin	• Before the initiation of treatment. • At Week 16.	µm, measured by Reflectance Confocal Microscopy (RCM)

Countries

France

Outcome results