Clinical Trial

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

Study acronym: ADUTERCoM
Recruiting
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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.
Trial Details
NCT Number NCT07568665
Lead Sponsor Hôpitaux Drôme Nord
Conditions Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
Enrollment 15 participants
Start Date 2025-11-27
Primary Completion 2027-02-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06