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Advances in dermatology and venereology Acta Dermato-Venereologica
Efficacy of Body Lotion Containing N-palmitoylethanolamine in Subjects with Chronic Pruritus due to Dry Skin: A Dermatocosmetic Study
Katharina VISSE 1, Christine BLOME 2, Ngoc Quan PHAN 1, Matthias AUGUSTIN 2 and Sonja STÄNDER 1 *
1
Department of Dermatology and Center for Chronic Pruritus, University Hospital Münster, Von-Esmarch-Str. 58, DE-48149 Münster, and
2
CVderm – German Center for Health Services Research in Dermatology, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. E-mail: sonja. staender @ uni-muenster. de Accepted Dec 8, 2016: Epub ahead of print Dec 8, 2016
Chronic pruritus( CP) is a frequent symptom in the general population and in many skin and systemic diseases( 1, 2). A population-based cohort study found the 12-month cumulative-incidence of CP to be 7 % and lifetime prevalence 25.5 %( 3). Determinants of prevalent CP, based on cross-sectional multivariate analysis, were: liver disease( prevalence ratio 2.1), asthma( 1.8), eczema( 2.7), increased body mass index( 1.0), higher anxiety scores( 1.1) and dry skin( 1.9)( 3).
Dry skin is characterized by a disrupted barrier, resulting in roughness, desquamation, lack of brightness of the skin surface and development of pruritus( 4). Therefore, the European Guideline on chronic pruritus recommends emollients as first-line therapy to restore the skin barrier and to induce relief of pruritus( 5). Topical N-palmitoylethanolamine( PEA) has been described as having emollient and antipruritic characteristics( 6 – 8). The aim of this study was to compare the effects of twice-daily application for 2 weeks of a derma-membrane system( DMS)-based dermatocosmetic lotion containing PEA with the vehicle in subjects with CP due to dry skin, with regard to symptom improvement, quality of life and cosmetic acceptance.
MATERIALS AND METHODS( see Appendix S1 1) RESULTS( see Table SI 1)
A total of 100 subjects were included and randomized either to the vehicle lotion( group 1, n = 51: 27 women, 24 men; age range 18 – 83 years, mean age 54.9 ± 16.7, median age 54.0 years) or to the PEA-containing lotion( group 2, n = 49: 29 women, 20 men; age range 24 – 83 years, mean age 59.5 ± 15.2, median age 61.0 years)( Fig. S1 1).
At baseline all subjects had pruritic dry skin with no further skin symptoms. Additional scratch lesions were observed in one-third of subjects in both groups.
Pruritus intensity, as assessed by visual analogue scale( VAS), decreased significantly from baseline and treatment onset( V1) to 2 weeks( V2)( p < 0.001) and considering pruritus intensity at study onset, only those subjects with severe pruritus( VAS > 7) at onset showed significant itch reduction from V1 to V2( p < 0.001, per protocol( PP))( Fig. 1). Differences between the 2 groups were not significant for either variable.
1 https:// www. medicaljournals. se / acta / content / abstract / 10.2340 / 00015555-2593
Pruritus, as assessed by verbal rating scale( VRS), decreased from V1 to V2( p = 0.223, PP) and from V1 to the follow-up visit 2 weeks after the end of treatment( V3)( p = 0.003, PP) across both groups. The decrease was significant only in the per-protocol analysis between V1 and V3.
Based on the percentage score, pruritus improved, on average, at V2( group 1: 24.2 ± 29.3 %, n = 40; group 2: 30.1 ± 29.8 %, n = 41; p = 0.378) and V3( group 1: 22.4 ± 30.5 %, n = 30; group 2: 28.6 ± 35.9 %, n = 22; p = 0.505) across both groups without significant group differences. Descriptively the improvement was rated higher in group 2. Stinging sensations increased nonsignificantly in group 1 from V1 to V2, and remained stable in group 2. This time-by-group effect was significant only in the PP analysis( p = 0.024).
Health-related QoL, as measured with the Dermatology Life Quality Index( DLQI), improved significantly from V1 to V2 across both groups( p < 0.001) without significant inter-group differences.
From V1 to V2, skin roughness increased slightly in group 1 and decreased in group 2. Differences between the groups were again not significant( p = 0.093).
Scaling decreased across both groups from V1 to V2( p = 0.118, PP) and from V1 to V3( p = 0.344, PP) without significance in the differences between the groups.
Chronic scratch lesions, such as prurigo, decreased in both groups from V1 to V2. The time effect was significant( p = 0.01), but the group differences were not( p = 0.833).
Fig. 1. Pruritus intensity at study visits as measured by visual analogue scale( VAS). In each group( group 1: derma-membrane system( DMS)-based lotion, no N-palmitoylethanolamine( PEA); group 2: DMS-based lotion with PEA), patients were divided into those with baseline < 7 vs. those with baseline ≥7( per protocol analysis, visit 1( V1) to visit 2( V2)). * p < 0.001.
This is an open access article under the CC BY-NC license. www. medicaljournals. se / acta Journal Compilation © 2017 Acta Dermato-Venereologica. doi: 10.2340 / 00015555-2593 Acta Derm Venereol 2017; 97: 639 – 641