Efficacy of Topical Palmitoylethanolamide (Levagen+) for the Management of Eczema Symptoms: A Double-Blind, Comparator-Controlled, Randomized Clinical Trial

Abstract

Introduction: Eczema is a debilitating skin disorder clinically characterised by the development of itchy, dry, rough, and scaling skin caused by a series of rudimentary clinical phenotypes. Methods: This double-blind, randomised, comparator-controlled trial evaluated the effectiveness of topical application of a novel palmitoylethanolamide formulation (Levagen+) compared with a standard moisturiser (comparator) to reduce eczema severity and improve patient outcomes. 72 participants aged over 18 years old with atopic eczema (symptoms including redness, dry skin, scaling and/or itchiness) on their hands or arm were recruited. Participants were randomly allocated to one of two treatment groups (Levagen+ or comparator). Treatment was applied to the affected area twice daily for 4-weeks. Outcome measures included Self-Assessed Eczema Area Severity Index (SA-EASI) scoring and Patient Oriented Eczema Measure (POEM) from baseline to week 4. Results: Both Levagen+ and a comparator cream were effective at alleviating symptom severity of eczema over 4 weeks. Levagen+ significantly reduced redness, dryness, and total POEM score compared to a comparator cream. Conclusion: Levagen+ can significantly reduce eczema symptom severity compared to a comparator product, supporting its use as a potential treatment for eczema. Trial registration: clinicaltrials.gov Identifier: NCT05003453