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

November 15, 2023 updated by: RDC Clinical Pty Ltd

The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • RDC Global Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (over 18)
  • Suffering from atopic eczema with symptoms of redness, dry skin, scaling and/or itchiness on hands or arms
  • Otherwise healthy
  • Able to provide informed consent

Exclusion Criteria:

  • Active allergic skin responses
  • Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, mood disorders, cancer)
  • Use of immunosuppressive medication within the last 3 months
  • Pregnant or lactating women
  • Smokers
  • Chronic past and/or current alcohol use (>14 alcoholic drinks week)

  • Allergic to any of the ingredients in active or comparator formula

    • An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Investigational product will be provided as a topical cream containing 1.5% PEA and participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.
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.
Other Names:
  • PEA, Levagen+
Placebo Comparator: Placebo comparator
A comparator placebo moisturiser cream (an unscented moisturizing base cream) will be provided and applied in the same manner as the active ingredient group. Participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.
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.
Other Names:
  • Moisturising cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema area and severity index (SA-EASI)
Time Frame: Baseline prior to commencement, Week 2 and Week 4
Change in eczema area and severity index (SA-EASI)
Baseline prior to commencement, Week 2 and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in itchiness (pruritus numerical rating scale)
Time Frame: Baseline prior to commencement, Week 2 and Week 4
Change in self-reported itchiness (pruritus numerical rating scale). Minimum value = 0, no pruritus. Maximum value = 10, Very severe pruritus.
Baseline prior to commencement, Week 2 and Week 4
Change in topical anti-inflammatory use
Time Frame: Baseline prior to commencement, Week 2 and Week 4
Change in self-reported topical anti-inflammatory use
Baseline prior to commencement, Week 2 and Week 4
Patient eczema self assessment (Patient Orientated Eczema Measure)
Time Frame: Baseline prior to commencement, Week 2 and Week 4
Improvement in POEM. Minimum value 0 - clear or almost clear, Maximum value 28 - Very severe eczema
Baseline prior to commencement, Week 2 and Week 4
Change in Quality of Life (DQOL)
Time Frame: Baseline prior to commencement, Week 2 and Week 4
Change in quality of life questionnaire scores
Baseline prior to commencement, Week 2 and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RDC Clinical Pty Ltd

Investigators

  • Principal Investigator: David Briskey, PhD, The University of Queensland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Actual)

June 3, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEA-XMA-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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