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

Recruitingn/aAges 18 Years - anyAllHôpitaux Drôme Nord
NCT07730788 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Nemolizumab is a a humanised anti-IL-31 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 nemolizumab.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18 years and older. * Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with nemolizumab * 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.
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What it tests

  • Not listed
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Where

1 site
Hôpitaux Drôme Nord
Romans-sur-Isère, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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