PELISTAD
Research type
Research Study
Full title
Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in pediatric patients with moderate to severe atopic dermatitis
IRAS ID
288115
Contact email
Sponsor organisation
Sanofi Aventis Recherche & Developpement
Eudract number
2020-001518-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 19 days
Research summary
Many patients with atopic dermatitis (also known as atopic eczema) have very dry skin, which contributes to itching, scratching and skin pain. This is thought to be partially due to increased evaporation of water from the skin and due to the change in the composition of lipids (a kind of fat tissue) in the skin. This study will evaluate the effect of dupilumab in 6-11 year old children with severe atopic dermatitis on the so-called skin barrier function. This will be done by analysing the evaporation of water from the skin before and after removal of the superficial skin by tape stripping. We will also use other non invasive imaging techniques including optical cohesive tomography and FTIR to assess the structure and function of the skin barrier. This will be evaluated over an approximate 6 month period. Similar aged healthy volunteers will also be recruited and undergo similar evaluation to act as a comparator.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0277
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion