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

Phase 2

Completed

• Conditions: Eczema, Atopic
• Interventions: Drug: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+; Drug: Placebo Comparator

• Registration Number: NCT05003453
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-12
• Study Start: 2021-11-29
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.5% Palmitoylethanolamide (PEA) sold as Levagen+	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.
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.

Primary Outcome Measures

Name	Time	Method
Eczema area and severity index (SA-EASI)	Baseline prior to commencement, Week 2 and Week 4	Change in eczema area and severity index (SA-EASI)

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (DQOL)	Baseline prior to commencement, Week 2 and Week 4	Change in quality of life questionnaire scores
Change in topical anti-inflammatory use	Baseline prior to commencement, Week 2 and Week 4	Change in self-reported topical anti-inflammatory use
Patient eczema self assessment (Patient Orientated Eczema Measure)	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
Change in itchiness (pruritus numerical rating scale)	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.

Trial Locations

Locations (1)

RDC Global Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia