The TREatment of severe Atopic eczema Trial (TREAT)

  • Research type

    Research Study

  • Full title

    A Randomised Controlled Trial Assessing the Effectiveness, Safety and Cost-effectiveness of Methotrexate versus Ciclosporin in the Treatment of Severe Atopic Eczema in Children: The TREatment of Severe Atopic Eczema Trial (TREAT)

  • IRAS ID

    182752

  • Contact name

    Carsten Flohr

  • Contact email

    carsten.flohr@kcl.ac.uk

  • Sponsor organisation

    Kings College London University

  • Eudract number

    2015-002013-29

  • ISRCTN Number

    ISRCTN15837754

  • Duration of Study in the UK

    2 years, 7 months, 30 days

  • Research summary

    TREAT is a study for children and young people with severe, difficult to manage eczema. Eczema treatment aims to reduce skin inflammation, relieve itching and prevent flare-ups. Usually, this can be achieved by regularly applying moisturisers and steroid creams. Although most children grow out of their eczema over time, in a small group of patients the disease is so severe that specialist medicines are needed.

    One way of treating severe eczema is to use medicines that help to dampen down the body’s immune system. Two medicines that are used in this way are methotrexate and ciclosporin. This study aims to find out which of these two medicines is the best to use in treating severe eczema in children and young people. We want to compare the two treatments in terms of:
    - how well they work
    - how they affect flare ups
    - the impact of the treatment on the patient’s quality of life
    - side effects or other problems that patients might experience when taking these medicines.

    We will recruit patients aged 2 to16 years with severe, difficult to manage eczema, attending one of the hospitals that are taking part in the study.

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    15/EE/0328

  • Date of REC Opinion

    16 Jan 2016

  • REC opinion

    Further Information Favourable Opinion