Adjuvante Therapie mit einer N-Palmitoylethanolamin-haltigen Creme bei Kindern mit atopischem Ekzem (ATOPA-Studie)

Abstract

The objective of this study was to yield data on the skin care properties of a cream with a unique lamellar matrix containing N-palmitoylethanolamine, and to assess quality of life variables during the management of patients with atopic eczema. In this multi-national, multicenter, observational, non-controlled, prospective cohort study 2456 patients (923 children ≤ 12 years) were enrolled. Outcome was followed over 38 days of adjuvant treatment with the study cream. Combined analysis of erythema, pruritus, excoriation, scaling, lichenification and dryness showed a significant score reduction by 58.6 % at study end for all patients (57.7 % for adults > 12 years and 60.5 % for children ≤ 12 years). Patients reported a significant reduction of pruritus on visual analogue scales as soon as 6 days after starting treatment and a further reduction at study end. Sleep quality improved significantly during the study period. Earlier used topical corticosteroids were omitted by 56 % of all patients (53.4 % in adults > 12 and 62.5 % in children ≤ 12 years) at study end and the average weekly application rate decreased from 7.9 to 3. The tolerance was assessed as very good or good in 92 % of cases by both patients and doctors. This study demonstrates substantial relief of objective and subjective symptoms of atopic eczema after regular skin care with the study cream over a period of 38 days. The requirement for treatment with topical corticosteroids was reduced in a substantial proportion of participants, which has potentially important pharmacoeconomic implications in the management of atopic eczema.