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

NCT05003453 | Completed Phase 2

• 1 other identifier: PEA-XMA-20
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Eczema area and severity index (SA-EASI)

  Change in eczema area and severity index (SA-EASI)

  Baseline prior to commencement, Week 2 and Week 4

Secondary Outcomes (4)

• Change in itchiness (pruritus numerical rating scale)

  Baseline prior to commencement, Week 2 and Week 4

• Change in topical anti-inflammatory use

  Baseline prior to commencement, Week 2 and Week 4

• Patient eczema self assessment (Patient Orientated Eczema Measure)

  Baseline prior to commencement, Week 2 and Week 4

• Change in Quality of Life (DQOL)

  Baseline prior to commencement, Week 2 and Week 4

Study Arms (2)

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

EXPERIMENTAL

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+

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

Interventions

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.

Also known as: PEA, Levagen+

1.5% Palmitoylethanolamide (PEA) sold as 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.

Also known as: Moisturising cream

Placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Global Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Related Publications (1)

• Rao A, Moussa AA, Erickson J, Briskey D. 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.

  PMID: 38408443 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

palmidrol

Condition Hierarchy (Ancestors)

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

Study Officials

• David Briskey, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: November 29, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)