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The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of Eczema

NCT05003453 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-11-18

No results posted yet for this study

Summary

This is a double blind, randomised, non-clinical study with 2 groups (1 investigational group and 1 comparator group) aiming to assess the effectiveness of PEA for reducing eczema severity compared to a base comparator moisturiser in healthy adults aged over 18 years.

Conditions

  • Eczema, Atopic

Interventions

DRUG

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area.

DRUG

Placebo Comparator

A comparator placebo topical moisturiser cream (an unscented moisturising base cream) applied to the affected site 2 times daily, liberally to coat and cover affected area.

Sponsors & Collaborators

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Principal Investigators

  • David Briskey, PhD · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-06-03
Completion
2022-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003453 on ClinicalTrials.gov