A study to evaluate the emollient performance of Doublebase Once
Research type
Research Study
Full title
A study to evaluate the emollient performance of Doublebase Once in the treatment of atopic eczema using SCORAD, patient questionnaires and skin hydration measurements
IRAS ID
341518
Contact name
Valerie Hart
Contact email
Sponsor organisation
Dermal Laboratories Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
A 4 week, open label, multi-centre (GP setting), post market clinical follow-up study to evaluate the emollient performance of Doublebase Once in patients of any age and any severity of atopic eczema. The study will involve patients who are already using emollients regularly as part of their treatment regime. Patients will be asked to use Doublebase Once only once daily instead of their usual emollient for 4 weeks. SCORAD assessments will be performed by the investigator at the beginning of the study and after 1 and 4 weeks of using Doublebase Once. Patients will complete questionnaires at the beginning and end of the study. The questionnaire asks patients about their quality of life before and after using Doublebase Once and how convenient they found using Doublebase Once only once daily. A subgroup of adult patients (up to 15 patients) will also undergo skin hydration measurements over the first 8 days to measure their skin hydration using a non-invasive instrument.
Photographs of the same, representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once.
REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0062
Date of REC Opinion
3 Jun 2024
REC opinion
Favourable Opinion