A Clinical Investigation of the Performance and Safety of Epaderm®, an Emollient Cream.

Abstract

IntroductionEmollients provide an occlusive barrier for dry and atopic skin, retain moisture, protect it from irritants, and form the basis of eczema treatment.Methods and AnalysisA prospective interventional single arm study to evaluate the performance and safety of Epaderm® Cream, an emollient and cleanser containing 25% (w/w) paraffin and 5% (w/w) glycerine (thereafter, an emollient cream), in patients with dry skin conditions. The primary outcome measure was participant evaluation of skin moisturisation after treatment with an emollient cream for up to 4 weeks. Secondary outcome measures included: evaluation of skin softness using a questionnaire and of pruritus on a visual analogue scale (VAS); clinician assessment of xerosis using Overall Dry Skin (ODS) score and measurement of skin hydration using a non-invasive device (MoistureMeterEpiD, Delfin Technologies) at each visit. Sign test and Wilcoxon signed rank test were used to analyse changes from baseline.ResultsA total of 114 participants completed the study. 84.2% (80 out of 95) of participants or parents strongly agreed or agreed that the cream improved skin moisturisation at 4 weeks of treatment at the target area (p<0.0001). 86.3% of participants agreed that skin softness improved after 4 weeks (p <0.0001). ODS score improved from 2.1 (standard deviation (SD) 1.0) to 0.7 (SD 0.8) at 4 weeks. Skin hydration at the target area improved from 31.5 (SD 9.3) to 40.5 (SD 8.3) (p<0.001) at 4 weeks. Mean skin itchiness reduced from 38.0 (SD 25.4) to 17.7 (SD 19.8) at 4 weeks (p<0.0001). Ten (8.3%) adverse device events (ADEs) were reported.ConclusionThe emollient cream was well tolerated and demonstrated significant improvements in patient-reported skin moisturisation and softness as well as in clinical measurement of xerosis and skin hydration across all age groups including infants. The emollient cream can be recommended for dry skin conditions including atopic dermatitis and psoriasis.