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

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    70
  • sponsor
    RDC Clinical Pty Ltd
Updated on 22 December 2021
eczema
dry skin
topical agents

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.

Details
Condition Eczema, Atopic
Treatment Placebo Comparator, 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Clinical Study IdentifierNCT05003453
SponsorRDC Clinical Pty Ltd
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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