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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eczema, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Investigational product will be provided as a topical cream containing 1.5% PEA and participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.

Group Type EXPERIMENTAL

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Intervention Type DRUG

A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area.

Placebo comparator

A comparator placebo moisturiser cream (an unscented moisturizing base cream) will be provided and applied in the same manner as the active ingredient group. Participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

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.

Interventions

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1.5% 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.

Intervention Type DRUG

Placebo 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.

Intervention Type DRUG

Other Intervention Names

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PEA, Levagen+ Moisturising cream

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No