Impact of daily use of emollient 'plus' on corticosteroid consumption in patients with atopic dermatitis: An open, randomized controlled study.

ABSTRACT

BACKGROUND: Emollients are the baseline treatment for mild or moderate atopic dermatitis (AD) to improve the epidermal barrier and provide anti-irritant and anti-pruritic effects. Emollient 'plus' can influence the skin microbiome of atopic eczema patients. OBJECTIVES: To evaluate the benefits of using Emollient 'plus' to reduce corticosteroid consumption. METHODS: In an open, single-centre, randomized, controlled study, patients with mild to moderate AD (Severity scoring of AD [SCORAD] score 20-30) were randomized 11 to apply the Emollient 'plus' twice daily for 28 days or to continue with their usual classical emollient (Control group). In addition, each patient received topical corticosteroids to use when necessary and according to the dermatologist's prescription. Assessments included SCORAD, PO-SCORAD, local SCORAD, quality of life questionnaires, and tolerability. RESULTS: A total of 119 patients were included in the PP population with a mean age of 26.50 ± 17.5 years old (min-max 3-71 years). Between baseline and day 28, the mean amount of corticosteroid used was lower for the Emollient 'plus' versus Control group (6.03 vs. 9.16 g; p = 0.041) and corticosteroid was applied on fewer days (37.5% vs. 46.9% of days; p = 0.0256) with fewer applications per day (0.55 vs. 0.71 applications per day; p = 0.0203). Similar improvements were observed in both groups for SCORAD, PO-SCORAD, local SCORAD, skin sensation score, AD burden scale, patient benefit index >1, as well as subject and investigator efficacy and tolerability questionnaire assessments. CONCLUSIONS: Between baseline and day 28, there was significant corticosteroid-sparing in the Emollient 'plus' group compared to the Control group in quantity, number of applications per day and number of days of use, whilst efficacy was maintained with no significant differences between the two groups for all clinical evaluations, as well as for tolerability.