Actively Recruiting
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
Led by Hôpitaux Drôme Nord · Updated on 2026-05-06
15
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older
- Moderate-to-severe Atopic Dermatitis requiring systemic treatment with tralokinumab as judged by the investigator
- Affiliated with or entitled to a social security scheme
- Capable of giving informed consent
- Received information about the study and co-signed an informed consent form with the investigator
You will not qualify if you...
- Patients who refuse to participate or are legally incapacitated
- Patients with uncontrolled chronic diseases that may require corticosteroid treatment
- Patients with severe concomitant diseases that might negatively affect study participation according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hopitaux Drome NOrd
Romans-sur-Isère, Drôme, France, 26100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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