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

Sponsor
RDC Clinical Pty Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05003453
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
  • Drug: Placebo Comparator
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
Actual Study Start Date :
Nov 29, 2021
Actual Primary Completion Date :
Jun 3, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • PEA, Levagen+

    		•
    Placebo Comparator: 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.

    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.
    Other Names:
  • Moisturising cream

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Eczema area and severity index (SA-EASI) [Baseline prior to commencement, Week 2 and Week 4]

      Change in eczema area and severity index (SA-EASI)

    Secondary Outcome Measures

    1. Change in itchiness (pruritus numerical rating scale) [Baseline prior to commencement, Week 2 and Week 4]

      Change in self-reported itchiness (pruritus numerical rating scale). Minimum value = 0, no pruritus. Maximum value = 10, Very severe pruritus.

    2. Change in topical anti-inflammatory use [Baseline prior to commencement, Week 2 and Week 4]

      Change in self-reported topical anti-inflammatory use

    3. Patient eczema self assessment (Patient Orientated Eczema Measure) [Baseline prior to commencement, Week 2 and Week 4]

      Improvement in POEM. Minimum value 0 - clear or almost clear, Maximum value 28 - Very severe eczema

    4. Change in Quality of Life (DQOL) [Baseline prior to commencement, Week 2 and Week 4]

      Change in quality of life questionnaire scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RDC Global Pty Ltd Brisbane Queensland Australia 4006

    Sponsors and Collaborators

    • RDC Clinical Pty Ltd

    Investigators

    • Principal Investigator: David Briskey, PhD, The University of Queensland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RDC Clinical Pty Ltd
    ClinicalTrials.gov Identifier:
    NCT05003453
    Other Study ID Numbers:
    • PEA-XMA-20
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Eczema
    Palmidrol

    Study Results

    No Results Posted as of Aug 8, 2022