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

Eczema, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003453
• Other study ID #: PEA-XMA-20
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 29, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: RDC Clinical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis, Atopic
• Eczema
• Eczema, Atopic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	RDC Global Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

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