What is the purpose of the study?
Up to 1 child in 5 has eczema. Many of these children are successfully treated by creams or medicines. However, a small number of these children have such severe eczema that the available medicines are unable to control their eczema. Other children have side effects from the medication, so that they cannot continue to take it.
The purpose of the study is to see if a new medication, Xolair (also known as omalizumab or anti-IgE), can help children with severe eczema who have not responded to other available treatments.
Who can take part in the study?
Children and adolescents aged 4-19 years old may be suitable if they have severe eczema which has not responded to routine treatment.
What are a parent's responsibilities during the study?
The greatest responsibility for parents/ guardians is to help ensure that their child carries out the required intervention throughout the study. This means helping their child attend their appointments, using their treatments at home, and monitoring their eczema in conjunction with the health care professionals.
How will families know what will happen during the study?
Parents/guardians are given a patient information sheet that details all aspects of the study, including the duration of the study and visit schedules where their child’s health will be monitored. Before agreeing for their child to participate, a member of the study team will explain the study and answer any questions they may have. Regulations require that parents/guardians sign a written agreement known as an ‘informed consent form’ to enable their child to take part. This records that the parent/guardian has been fully informed of the nature of the clinical study and that they are willing for their child to participate.
What type of care will participants receive during the study?
The clinical study team consists of a group of paediatric allergy specialists including doctors, nurses and other healthcare professionals, all of who are committed to the health and well-being of the children involved. They will check the health of each child at the beginning of the study, provide clear instructions to parents/guardians about what participation involves and carefully monitor the health of each child throughout the study.
How are children protected during the study?
An independent ethics committee has already reviewed and approved the study in line with regulations set up to protect the public. This committee can be made up of doctors, nurses, and people from the community, who check that the rights and safety of study participants are protected. The clinical study team are a group of health care experts who are regulated by their own professional bodies and they will continuously monitor your child’s health and well-being throughout the study.
What is Xolair?
Xolair (manufactured by Novartis) is also known as omalizumab. Xolair is currently licensed for patients with severe asthma. It is a type of medicine known as anti-IgE. IgE is a protein produced by the immune system which may be important in children with eczema. Anti-IgE (Xolair) binds to IgE to counteract its effects. Reducing the levels of available IgE in children with eczema may therefore improve their eczema.
Will it cost anything to participate?
Other than your time, the medication will be provided at no cost to you. You will be reimbursed for reasonable travelling costs incurred in travelling to and from the hospital for study visits.
What are the possible benefits of taking part?
Ultimately we hope that the treatments in this study will help your child. However there is no guarantee that your child’s eczema will get better if they participate in the study. We hope that the information we get from this study may help us to find better treatments for children with severe eczema, which have fewer side effects.
Will my child's taking part in the study be kept confidential?
All information which is collected about you and your child during the course of the research will be kept strictly confidential. Any information which leaves the hospital will have your/your child’s name and address removed so that you cannot be recognised from it. Research folders will be kept in a secured office at all times. Access to these folders will be restricted to study investigators, study statisticians, the NHS R&D office, monitors, audit and regulatory authorities. Any information that is stored electronically will be kept ‘locked’ by password access. Your GP will be informed that your child is taking part in the study and of any diagnoses (e.g. asthma) that may be made during the study, unless you inform us that you prefer that this does not happen.
What will happen to the results of the study?
Once the study is completed the information will be analysed and then submitted for publication to at least 1 peer reviewed scientific journal. No information that will allow the identification of any of the participants will be included in the publication. Once again all the study findings will be made available to participants and their families.
Can I withdraw?
Parents/guardians are under no obligation to keep their child in the study and may withdraw from the study at any time. The rights of the child and the parents/guardians are a highly important consideration in every clinical study and parents/guardians are encouraged to ask the study team any questions they may have during the study.
Who is conducting and funding the research?
The study is being run by Prof Gideon Lack, Dr Susan Chan and their team of researchers. The research will be funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme and the Guy’s and St Thomas’ Charity. The medication will be provided by the manufacturers, Novartis.
What if I still have questions?
If you would like more information on the study, please contact the study team.