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

RDC Clinical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Eczema, Atopic

Treatments: Drug: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05003453

PEA-XMA-20

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Experimental group

Description:

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.

Treatment:

Drug: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Placebo comparator

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Comparator