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Clinical Trials in France / NCT07568665
Active, not recruiting Observational

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

NCT07568665 · tracked via the Priya Life Science France tracker
Sponsor
Hôpitaux Drôme Nord
Phase
Observational
Started
2025-11-27
Last updated
2026-09-03

Condition(s) studied

Atopic Dermatitis (AD)Atopic Dermatitis (Eczema)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Hopitaux Drome NOrd Romans-sur-Isère Drôme

More Hôpitaux Drôme Nord trials in France

Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab Recruiting

Other trials for the same condition

Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function Recruiting
Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568665 on ClinicalTrials.gov ↗ ← All trials in France