Extract

Background and study aims Eczema, also known as dermatitis, is a long-term medical condition which causes the skin to become dry, itchy and inflamed (swollen and red). Atopic eczema (AE) is the most common type of eczema, particularly in children. It can appear anywhere on the body, but it is usually found on the face, trunk (chest and back) and around the inside of the elbows or knees. This type of eczema is called “atopic” because sufferers are more sensitive to allergens (substances which can cause an allergic reaction). The exact cause of AE is not fully understood, but it is thought that their skin does not produce as many protective oils as it should do and so the skin loses water easily. This means that the protective barrier of the skin is not as good as it should be, and so it is more vulnerable to potential irritants. When the AE symptoms are particularly severe, it may be necessary to apply skin creams containing corticosteroids (powerful anti-inflammatory medicine). Although this type of treatment is generally effective, many children do not feel that it makes any difference to their condition. The aim of this study is to compare the short- and long-term effectiveness and safety of the immunosuppressive drugs methotrexate and ciclosporin for the treatment of severe atopic eczema in children. Who can participate? Children aged between 2 and 16 who have severe atopic eczema and have not responded well to previous corticosteroid skin cream treatments. What does the study involve? Participants are randomly allocated to one of two groups. Group 1 participants are treated with ciclosporin for 9 months. Group 2 participants are treated with methotrexate for 9 months. Participants in both groups are followed-up for another 6 months to assess the short- and long-term effectiveness and safety of the drugs. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Medicines for Children Clinical Trials Unit, University of Liverpool (UK) When is the study starting and how long is it expected to run for? May 2016 to April 2019 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Miss Farhiya Ashoor

Inclusion criteria

• Topic: Children, Dermatology; Subtopic: Children (all Diagnoses), Dermatology (Skin); Disease: All Diseases, Dermatology

Links

• isrctn
• ictrp