Efficacy and Tolerability of a Medical Device Repairing Emollient Cream Associated with a Topical Corticosteroid in Adults with Atopic Dermatitis: An Open-label, Intra-individual Randomized Controlled Study

摘要

IntroductionMedical device repairing emollient creams (MDRECs) are designed to repair and protect the skin barrier. In this study, we examined the added clinical benefit and tolerability of a MDREC when used in association with a moderately potent topical corticosteroid (TCS) for adults with atopic dermatitis (AD). MethodsThis was an intra-individual randomized controlled trial in adults with moderate to severe AD (EudraCT no. 2014-002,194-10). Symmetrical lesions on each arm of the subjects were randomized to treatment for 10 days with twice-daily TCS (desonide) cream alone or with combined TCS?+?MDREC. Subjects were then included in a following 2-week maintenance phase if the AD on at least one test area had sufficiently improved so that the treatment was no longer needed. During the maintenance phase, treatment with the TCS cream was stopped, but twice-daily application of the MDREC was continued on the same test area previously assigned to receive it. The primary outcome measure was the change in local Scoring Atopic Dermatitis (SCORAD) index between day 1 and 3 based on investigators’ assessment. Secondary measures of lesion severity included changes in the local patient-oriented SCORAD index, pruritus intensity according to subjects’ assessments, and global assessments by subjects and investigators. ResultsThe study included 54 subjects. The change in investigator-observed local SCORAD index between day 1 and 3 was ??14.4% with TCS alone and ??24.5% for TCS?+?MDREC ( p =?0.0005). Between baseline and the end of the treatment phase, all secondary measures of lesion severity decreased more with the combined TCS?+?MDREC treatment than with the TCS cream alone. The MDREC also reduced the relapse of AD lesions during the maintenance phase. Tolerability was very good, and the product was well accepted by subjects. ConclusionThese results support using the MDREC in association with TCS during AD flares and as a maintenance therapy after treatment with TCS has stopped. FundingLaboratoires Dermatologiques Ducray, Pierre Fabre.