DELP-04: Comparison of the effect of four emollients on skin hydration
Research type
Research Study
Full title
A randomised, double-blind, within subject comparison to investigate the effect of four emollients on skin hydration.
IRAS ID
147914
Contact name
Amanda Wigens
Contact email
Sponsor organisation
Dermal Laboratories Limited
Eudract number
2013-005465-40
Clinicaltrials.gov Identifier
RCA/0715/01, RCRAspect Reference Number
Duration of Study in the UK
0 years, 0 months, 19 days
Research summary
Despite the general recognition of the importance of regularly using emollients (moisturisers) for the management of eczema, there is a lack of good quality evidence on how well different emollients are able to moisturise the skin. This information would be very useful for health professionals to help select the right treatment for their patients, and to better advise their patients on how often to apply their usual emollient(s) in order to manage their skin condition properly; based on the emollient’s performance and the patient’s individual circumstances.
In this study, we are comparing the ability of four widely used, commercially available emollients to increase and maintain skin moisturisation over a period of 12 hours, following a single application to the forearms of approximately 25 consenting adult female volunteers with eczema, aged between 16 to 65 years old.
Participants 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 products, and asked not to apply any leave-on moisturising products or any other skin treatments to their forearms (i.e. from the elbow to the wrist). Subjects will then be asked to return to the study centre to have their first skin measurements taken and to confirm they are still suitable to take part in the study. Each participant will have a small amount of the four products applied to selected application areas on the forearms by a designated study centre staff member. Participants will then be required to stay at the study centre in order to have their skin measurements approx. 1, 2, 3, 4, 6, 8 and 12 hours after application; after which their participation in the study will come to an end.
This trial is anticipated to be completed within approximately 6 weeks.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0001
Date of REC Opinion
21 Jan 2016
REC opinion
Favourable Opinion