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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Briskey, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Global Pty Ltd | Brisbane | Queensland | 4006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38408443 | Derived | 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. |
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No IPD will be shared
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
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|
| 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. |
|
|
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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |