The Order of Application of Creams in Children with Eczema (ACE) Study
Research type
Research Study
Full title
A Pilot Feasibility Study on the Application of Topical Corticosteroids Before or After Emollients in the Management of Eczema in Paediatric Patients.
IRAS ID
237644
Contact name
Tim Clayton
Contact email
Sponsor organisation
Research and Devleopment Department
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Eczema is a chronic burdensome condition estimated to affect 15-20% of school children and 2-3% of adults in the UK. In the 1990’s, the estimated annual cost of eczema was £465 million and these costs are likely to have risen substantially since then. Eczema is a complex multifactorial condition. The mainstay of treatment involves the use of liberal emollient use and topical corticosteroids to help control the patient’s dry, itchy skin.
Patients often receive conflicting advice from friends, family and non-specialist healthcare providers which can confuse patients and hinder treatment adherence. Whilst dermatologists broadly agree on many aspects of eczema management, opinion is divided regarding the order of application of two key treatments; emollients and topical steroids.
Some clinicians strongly advocate the application of emollients prior to the application of topical steroids whilst others advocate the reverse. It is important to establish if one treatment regimen is superior to the other, and the magnitude of any difference.
We intend to clarify this issue by investigating the order of application of steroids and emollients in children aged 4-16 with a confirmed diagnosis of moderate to severe eczema. Following consent and assent to the trial, participants will be randomly allocated to treatment with either application of topical corticosteroid or emollients first. We will obtain 50g tubes of diprobase and synalar 1 in 4. We intend to put either a number of 1 or 2 on each tube as a reminder to the participants of the order of application. We intend to randomly allocate participants to either trial arm by a 1:1 simple randomization process through computer-generated numbers 1 or 2 on excel spreadsheet. We will write ‘1st’ on the treatment to be applied first and ‘2nd’ on the treatment to applied second. Participants will receive the treatments which they will self-apply following training. The severity of the child’s eczema will be scored through objective and subjective measures (EASI & cDLQI). Participants will be reviewed at week 0,1,2 and 4.
We aim to recruit participants to this study from those patients encountered in the paediatric dermatology clinics. We will submit the results of this study for publication in established dermatology and paediatric journals. The results of the study will help us to provide guidance on the impact of the order of application of topical corticosteroids and emollients on paediatric eczema severity.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0520
Date of REC Opinion
26 Feb 2020
REC opinion
Further Information Favourable Opinion