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

Phase

2/3

Condition

Hives (Urticaria)

Atopic Dermatitis

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT05003453

PEA-XMA-20

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults (over 18)
Suffering from atopic eczema with symptoms of redness, dry skin, scaling and/oritchiness on hands or arms
Otherwise healthy
Able to provide informed consent

Exclusion

Exclusion Criteria:

Active allergic skin responses
Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, mooddisorders, 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 astable dose of medication or is fluctuating in severity. A serious illness is acondition that carries a risk of mortality, negatively impacts quality of lifeand daily function and/or is burdensome in symptoms and/or treatments.

Study Design

November 29, 2021

June 30, 2022

Connect with a study center

RDC Global Pty Ltd
Brisbane, Queensland 4006
Australia
Site Not Available

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