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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area.
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.
RDC Global Pty Ltd
Brisbane, Queensland, Australia
Eczema area and severity index (SA-EASI)
Change in eczema area and severity index (SA-EASI)
Time frame: Baseline prior to commencement, Week 2 and Week 4
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.
Time frame: Baseline prior to commencement, Week 2 and Week 4
Change in topical anti-inflammatory use
Change in self-reported topical anti-inflammatory use
Time frame: 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
Time frame: Baseline prior to commencement, Week 2 and Week 4
Change in Quality of Life (DQOL)
Change in quality of life questionnaire scores
Time frame: Baseline prior to commencement, Week 2 and Week 4
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