DELP-05: Comparison of two emollients in patients with dry skin
Research type
Research Study
Full title
Randomised, double-blind, bilateral comparison of two emollients in patients with dry skin
IRAS ID
159109
Contact name
Amanda Wigens
Contact email
Sponsor organisation
Dermal Laboratories Limited
Eudract number
2014-001026-16
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
Eczema patients suffer from dry skin, which is not as effective as ‘healthy’ skin at preventing the penetration of substances which may trigger their condition to ‘flare’. The NICE guidelines recommend the frequent, widespread and liberal use of emollients (even if the eczema is clear) to help keep the skin hydrated and thereby restore its natural barrier. However, this is not always practical while patients are going about their daily routine and, in reality, many may only apply their prescribed emollients once in the morning before dressing, and again in the evening before going to bed.
This study is being conducted to compare (using corneometry) the ability of two emollients currently marketed in the UK to improve and maintain skin hydration in atopic eczema patients; when applied only twice daily over a period of 5 days.
The study will involve 20 adult female atopic eczema patients aged 16 to 65 years old with dry skin on their lower legs. Prior to starting applying the study treatments, the patients will be entered into a 1 week washout/run-in period where they will be given a standard soap to use instead of their usual washing products, and asked not to apply any moisturising products to their lower legs. Patients will then be asked to apply the two study emollients to their respective lower legs only, continuing with their usual topical treatments elsewhere. They will be required to visit the study centre three times daily over a period of 5 days in order to conduct the skin corneometry measurements. At the end of the treatment, patients will be given a questionnaire to record their opinion on the cosmetic acceptability of the products tested.
It is envisaged that the clinical phase of this trial will be completed within approximately 2 months.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0141
Date of REC Opinion
1 Apr 2015
REC opinion
Further Information Favourable Opinion