Condition category
Skin and Connective Tissue Diseases
Date applied
01/05/2014
Date assigned
01/05/2014
Last edited
21/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Eczema is a common childhood condition where the skin is dry and itchy. It is usually diagnosed in the first two years of life and in the UK most children are treated by their General Practitioner (GP). Moisturisers (emollients) are the main treatment for eczema but there are many types and we do not know whether one is better than another. This is a problem because patients may have to make several appointments before they are given an emollient that works for them and it may be that older, cheaper emollients are as good as, or better, than newer, more expensive ones. We want to find out whether it is possible to conduct a large study that will answer the question 'What is the most clinically and cost effective primary emollient to use in infants with eczema?'.

Who can participate?
Parents/carers of 160 children with eczema who are younger than 3 years old can participate in this study.

What does the study involve?
Participants will be prescribed at random one of four widely available emollients (either a cream, a lotion, a gel or an ointment) to use regularly for 3 months. During this time carers will be asked to complete daily diaries about their child's symptoms and use of emollients and other treatments for eczema, and a researcher will assess the severity of eczema at monthly intervals.

What are the possible benefits and risks of participating?
At the end of this study we will have some useful information about the use of emollients and how to assess their effectiveness. We will also be able to decide if it is possible to conduct a larger study. Findings from this and the future study will improve the decision making around which emollient to prescribe first in infants with eczema.

Where is the study run from?
The study is being run by the University of Bristol, in collaboration with 16 GP practices throughout Bristol, North Somerset and South Gloucestershire, UK.

When is the study starting and how long is it expected to run for?
The study starts in June 2014 and runs until August 2015.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Victoria J Wilson
Victoria.Wilson@bristol.ac.uk

Trial website

http://www.bristol.ac.uk/comet

Contact information

Type

Scientific

Primary contact

Dr Victoria J Wilson

ORCID ID

Contact details

Centre for Academic Primary Care
School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
-
Victoria.Wilson@bristol.ac.uk

Additional identifiers

EudraCT number

2013-003001-26

ClinicalTrials.gov number

Protocol/serial number

16571

Study information

Scientific title

Choice Of Moisturiser in Eczema Treatment (COMET): a feasibility study for a pragmatic, single blind, randomised clinical trial to compare the clinical and cost effectiveness of leave-on emollients in treatment of infant eczema in primary care

Acronym

COMET

Study hypothesis

Can a study comparing the effectiveness of four different moisturisers used to treat children with eczema be done?

Ethics approval

13/SW/0297; First MREC approval date 19/11/2013

Study design

Feasibility study of a single-centre four-arm single-masked randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children, Primary Care; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases

Intervention

The participants will be randomised to receive one of four commonly prescribed emollients (Diprobase® cream, Aveeno® lotion, Doublebase® gel or Hydromol® ointment), with directions to apply topically twice daily and throughout the day as required. They will be followed up every 28 days by the clinical studies officers, for 3 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Adherence and retention; Timepoint(s): 3 months

Secondary outcome measures

1. Blinding; Timepoint(s): 3 months
2. Data completeness; Timepoint(s): 3 months
3. EASI; Timepoint(s): Day 0, 28, 56 & 84
4. MCID of biophysical and objective eczema severity measures; Timepoint(s): 0, 1, 2 and 3 months
5. POEM; Timepoint(s): Weekly for 84 days
6. SASSAD; Timepoint(s): Day 0, 28, 56 & 84
7. TIS; Timepoint(s): Day 0, 28, 56 & 84

Overall trial start date

01/06/2014

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged between 1 month and 3 years of age with doctor-diagnosed eczema
2. Adult with parental responsibility available to give consent
Target Gender: Male & Female; Upper Age Limit 3 years ; Lower Age Limit 1 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160

Participant exclusion criteria

Child known to be sensitive or allergic to any of study emollients or their constituents

Recruitment start date

01/06/2014

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Academic Primary Care, School of Social and Community Medicine
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research & Enterprise Development (RED)
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 2PS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK); Grant Codes: PB-PG-0712-28056

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26170126
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27852708
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27855723

Publication citations

Additional files

Editorial Notes

21/11/2016: Publication reference added. 18/11/2016: Publication reference added.