Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpitaux Drôme Nord
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
adult patint with moderate to severe Atopic Dermatitis who require systemic treatment with nemolizumab
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Thickness of the atopic skin
µm, measured by Reflectance Confocal Microscopy (RCM)
Time frame
at week 16Sponsors and contacts
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Source ClinicalTrials.gov