CREAM was a double blind, randomised controlled trial to assess whether children with eczema benefitted from antibiotic treatment and was based in general practices and dermatology clinics in Wales, Scotland, and the West of England.
Eczema is a common, debilitating skin condition in young children that causes dryness and itching. Everyone naturally has bacteria on their skin, although one called Staphylococcus aureus may be found more frequently on the skin of children with eczema. The presence of these bacteria may make the eczema worse. However, studies of treatments designed to eliminate or reduce Staphylococcus aureus have been unclear. It was not known whether children consulting a general practitioner with eczema, which is suspected to be infected, would benefit from antibiotic treatment. Furthermore, it was not known if taking an antibiotic by mouth or using an antibiotic cream on the skin was more effective.
CREAM was a double blind, randomised controlled trial based in general practices and dermatology clinics in Wales, Scotland, and the West of England. Children aged between 3 months and under 8 years’ old who were eligible for the study were identified by General Practitioners. If the child’s parent/carer agreed, children were randomly assigned to one of three treatment groups (for one week):
1. oral antibiotic and placebo cream;
2. oral placebo and antibiotic cream; or
3. oral placebo and placebo cream.
A research nurse visited each child during the first 4 weeks and used established questionnaires to assess the severity of eczema; quality of life; healthcare consultations; impact on the family; and took swabs from the skin, nose and mouth. The child’s parent/carer was asked to complete a diary during the first 4 weeks to record symptom severity and use of medication. At 3 months, the parent/carer was asked to complete questionnaires and repeat swabs. These swabs were used to assess impact of treatments on bacterial resistance, to determine the relationship between antibiotic use and subsequent development of antibiotic resistance, and to measure the antibiotic sensitivity of bacteria found on the skin, nose and mouth.
Involving the public and patients
CREAM benefitted from an extremely experienced patient and public involvement representative, who has sat on a number of bodies including the patient panel at the Centre for Evidence Based Dermatology. She also set up a support group for parents of children with eczema (Nottingham Support Group for Carers of Children with Eczema) and through this has had direct contact with many carers of children with eczema.
Some of the key areas she contributed to include reviewing parent and child information sheets, providing feedback on the study protocol, logo and randomisation process, and providing guidance on strategies for successful recruitment. The acceptability of the study design from a public and patient perspective is reflected in the positive feedback from participants and the follow-up rates that were achieved.
|Start date||1 Jun 2012|
|End date||31 May 2015|