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

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RDC Clinical Pty Ltd
• Treatments: Palmidrol

Criteria

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.