Epaderm01
Research type
Research Study
Full title
A prospective post market clinical study with Epaderm® Cream to confirm performance and safety parameters
IRAS ID
251156
Contact name
Suzannah August
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. The purpose of the study is to collect data to confirm how effective Epaderm Cream is as a daily treatment for dry skin conditions over a 4 week period. Data will be collected from approximately 120 participants, divided into three groups of approximately 40 each; infants (0-36 months old), children (3-18 years old) and adults (>18 years old), with dry skin conditions (including conditions such as eczema, psoriasis, xerosis and ichthyosis).
Each participant will be followed up for 4 weeks, with a visit at baseline (visit 1), at 2 weeks (visit 2) and at 4 weeks (visit 3). The study will be conducted in both a hospital setting (outpatient clinics and wards) and in GP surgeries. The participants will complete questionnaires about whether Epaderm provided improved moisturisation and softness of their skin. Clinicians will provide clinical assessments of dryness of skin. Also, a non-invasive device will be used to measure hydration (water content) in the skin objectively.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2232
Date of REC Opinion
17 Dec 2018
REC opinion
Favourable Opinion