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

Primary Purpose

Eczema, Atopic

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Placebo Comparator
Sponsored by
RDC Clinical Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema, Atopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • RDC Global Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1.5% Palmitoylethanolamide (PEA) sold as Levagen+

Placebo comparator

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in itchiness (pruritus numerical rating scale)
Change in self-reported itchiness (pruritus numerical rating scale). Minimum value = 0, no pruritus. Maximum value = 10, Very severe pruritus.
Change in topical anti-inflammatory use
Change in self-reported topical anti-inflammatory use
Patient eczema self assessment (Patient Orientated Eczema Measure)
Improvement in POEM. Minimum value 0 - clear or almost clear, Maximum value 28 - Very severe eczema
Change in Quality of Life (DQOL)
Change in quality of life questionnaire scores

Full Information

First Posted
August 6, 2021
Last Updated
August 4, 2022
Sponsor
RDC Clinical Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05003453
Brief Title
The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of Eczema
Official Title
The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDC Clinical Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Arm Type
Experimental
Arm 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.
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Other Intervention Name(s)
PEA, Levagen+
Intervention Description
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
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
Moisturising cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eczema area and severity index (SA-EASI)
Description
Change in eczema area and severity index (SA-EASI)
Time Frame
Baseline prior to commencement, Week 2 and Week 4
Secondary Outcome Measure Information:
Title
Change in itchiness (pruritus numerical rating scale)
Description
Change in self-reported itchiness (pruritus numerical rating scale). Minimum value = 0, no pruritus. Maximum value = 10, Very severe pruritus.
Time Frame
Baseline prior to commencement, Week 2 and Week 4
Title
Change in topical anti-inflammatory use
Description
Change in self-reported topical anti-inflammatory use
Time Frame
Baseline prior to commencement, Week 2 and Week 4
Title
Patient eczema self assessment (Patient Orientated Eczema Measure)
Description
Improvement in POEM. Minimum value 0 - clear or almost clear, Maximum value 28 - Very severe eczema
Time Frame
Baseline prior to commencement, Week 2 and Week 4
Title
Change in Quality of Life (DQOL)
Description
Change in quality of life questionnaire scores
Time Frame
Baseline prior to commencement, Week 2 and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Briskey, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
RDC Global Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

Learn more about this trial

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

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