Actively Recruiting
Study of Skin Changes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Using Confocal Reflectance Microscopy
Led by Hôpitaux Drôme Nord · Updated on 2026-05-06
15
Participants Needed
1
Research Sites
91 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying atopic dermatitis AD, a long-lasting inflammatory skin condition marked by itchiness and recurring eczema. They aim to assess skin changes in patients treated with tralokinumab, an antibody therapy targeting IL-13 that has shown promise for moderate-to-severe AD. Traditional assessments rely on clinical scores like Eczema Area Severity Index EASI and SCORAD, which can vary between observers. This study uses reflectance confocal microscopy RCM, a noninvasive imaging technique that examines the skin at the cellular level to better understand treatment effects. Participants with moderate-to-severe AD who are starting treatment with tralokinumab will be observed. The study will evaluate skin thickness and other structural changes before treatment begins and at 16 weeks after starting therapy using RCM. This observational study does not involve altering patient treatment but monitors skin changes during standard care with tralokinumab. During the study, participants will undergo RCM imaging to assess skin layers and inflammation. Researchers will measure the thickness of affected skin before treatment and at week 16 to track changes. Patients must provide informed consent and be able to participate for the duration of the study. The total study period extends through November 2028, with ongoing observation of skin responses to therapy.
CONDITIONS
Brief Title
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
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