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.