Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time?

DESIGN:

This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants.

DISCUSSION:

Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients.

TRIAL REGISTRATION:

Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

• Authors: Matthew J Ridd, Niamh M Redmond, Sandra Hollinghurst, Nicola Ball, Lindsay Shaw, Richard Guy, Victoria Wilson, Chris Metcalfe, Sarah Purdy
• Journal: Trials (Trials) Vol. 16 Pg. 304 (Jul 15 2015) ISSN: 1745-6215 [Electronic] England
• PMID: 26170126 (Publication Type: Journal Article, Pragmatic Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Emollients
• Ointments

Topics

• Administration, Cutaneous
• Child, Preschool
• Clinical Protocols
• Cost-Benefit Analysis
• Drug Costs
• Eczema (diagnosis, drug therapy, economics)
• Emollients (administration & dosage, adverse effects, economics)
• England
• Feasibility Studies
• Female
• Humans
• Infant
• Male
• Ointments
• Patient Selection
• Primary Health Care
• Research Design
• Single-Blind Method
• Skin (drug effects, pathology)
• Time Factors
• Treatment Outcome