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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Thickness of the atopic skin | µm, measured by Reflectance Confocal Microscopy (RCM) | • Before the initiation of treatment. • At Week 16. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopitaux Drome NOrd | Recruiting | Romans-sur-Isère | Drôme | 26100 | France |
data will be shared via Mendeley
01/jun/2026 to 01/nov/2029
via Mendeley connection
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |