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NCT Number: NCT05003453

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

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.

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Key information

Conditions

Eczema, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

RDC Global Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Drug

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

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  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

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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