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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