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

Study Overview
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Brief Summary
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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.

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

Conditions
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Eczema, Atopic

Intervention / Treatment
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* Drug: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+<br>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+<br>* A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area.<br>* Other names: PEA, Levagen+;|
| Placebo Comparator: Placebo comparator<br>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<br>* 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.<br>* Other names: Moisturising cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in topical anti-inflammatory use | 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) | 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) | Change in quality of life questionnaire scores | Baseline prior to commencement, Week 2 and Week 4 |