Adjuvant treatment of atopic eczema: assessment of an emollient containing N-palmitoylethanolamine (ATOPA study)

Background For long-term management of atopic eczema, the use of skin care creams is recommended, but effectiveness of this treatment is not well established. Objective 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 (PEA) and to assess quality-of-life variables in patients with mild to moderate atopic eczema. Setting In this multinational, multicentre, observational, non-controlled, prospective cohort study, patients between 2 and 70 years of age were enrolled. All patients were supplied with the study product sufficient for treatment over the entire study period. Outcome was followed in periods between 3 and 7 days and 4 and 6 weeks after study start. Data were gathered from doctor reports and patient self-assessments via patient questionnaires. Results Data from 2456 patients entered the database. The mean examination intervals were 6 days for the 3- to 7-day period and 38 days for the 4- to 6-week period. At study end, intensities of erythema, pruritus, excoriation, scaling, lichenification and dryness were significantly reduced with a combined score reduction of 58.6% in the entire population (57.7% in adults > 12 years and 60.5% in children <= 12 years) according to doctors' reports. Patients reported a reduction of pruritus on visual analogue scales from 4.9 +/- 2.6 to 2.7 +/- 2.4 6 days after treatment start and a further reduction to 2.0 +/- 2.3 at study end (P < 0.001 each). Likewise, sleep quality improved significantly during the study period. Earlier-used topical corticosteroids were omitted by 56% of all patients (53.4% in adults and 62.5% in children) at study end, and the average weekly application rate decreased by 62% from 7.9 +/- 6.0 to 3.0 +/- 5.1 (P < 0.001). The tolerance was assessed as very good or good in 92% of cases by both patients and doctors. Conclusion This study showed substantial relief of objective and subjective symptoms of atopic eczema after regular skin care with the study cream. The patient-related effectiveness (decline of pruritus and loss of sleep) indicated a gain in quality of life in these patients. The reduced use of topical corticosteroids is important in view of safety and pharmacoeconomic implications in the treatment of atopic eczema.