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

Skin Pharmacol Physiol. 2023;36(6):288-295. doi: 10.1159/000536670. Epub 2024 Feb 26.

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. Seventy-two 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: Levagen+ was 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: <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</ext-link> Identifier: NCT05003453.

Keywords: Allergy; Alternative medicine; Anti-inflammation; Atopic eczema; Dermatology; Disease management; Eczema; Palmitoylethanolamide; Skin disease.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Amides / therapeutic use
  • Dermatitis, Atopic* / drug therapy
  • Double-Blind Method
  • Eczema* / drug therapy
  • Ethanolamines / therapeutic use
  • Humans
  • Palmitic Acids*
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Amides
  • Ethanolamines
  • palmidrol
  • Palmitic Acids

Associated data

  • ClinicalTrials.gov/NCT05003453

Grants and funding

Gencor Pacific. Rm 3 1/F Office Bldg Blk 2 96 Siena Ave, Discovery Bay North Lantau Island Hong Kong, provided investigational product and funding for the research. The sponsor had no input into the design, conduct, data analysis, or preparation of the manuscript.