CREAM

CREAM is a double blind, randomised controlled trial to assess whether children with eczema will benefit from antibiotic treatment and is based in general practices and dermatology clinics in Wales, Scotland, and the West of England.

Background

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 is not known whether children consulting a general practitioner with eczema, which is suspected to be infected, will benefit from antibiotic treatment. Furthermore, we do not know if taking an antibiotic by mouth or using an antibiotic cream on the skin is better.

We are conducting a study, led by Dr Nick Francis, funded by the Department of Health's National Institute for Health Research Health Technology Assessment Programme that aims to answer these questions.

Study design

CREAM is 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 are eligible for the study will be identified by General Practitioners. If the child’s parent/carer agrees, children will be randomly put into 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 will visit each child during the first 4 weeks and use established questionnaires to assess the severity of eczema; quality of life; healthcare consultations; impact on the family; and take swabs from the skin, nose and mouth. The child’s parent/carer will be asked to complete a diary during the first 4 weeks to record symptom severity and use of medication. At 3 months, the parent/carer will be asked to complete questionnaires and repeat swabs. These swabs will be 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 benefits 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 has 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 contributes 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 being achieved.

Information

Key facts

Start date 1 Jun 2012
End date 31 May 2015
Grant value £682,463
Status
  • Main report in press

General enquiries

User:
Emma Thomas-Jones
Email:
thomas-jonese@cardiff.ac.uk
Telephone:
+44 (0)29 2068 7520