Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
Recruiting · NCT07568665 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hôpitaux Drôme Nord
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab in the investigator's opinion.
- 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.
Where it is running
1 location listed.
- Hopitaux Drome NOrd - Romans-sur-Isère, Drôme, France