Eczema, Atopic
Conditions
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.
Interventions
DRUG1.5% 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.
DRUGPlacebo 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.
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Quality of Life (DQOL) | Baseline prior to commencement, Week 2 and Week 4 | Change in quality of life questionnaire scores |
| 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. |
| Change in topical anti-inflammatory use | Baseline prior to commencement, Week 2 and Week 4 | Change in self-reported topical anti-inflammatory use |
Countries
Australia
Outcome results
None listed