Eczema, AtopicPhase 2/3NCT05003453
The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of Eczema
A Phase 2/3 study testing 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ in people with Eczema, Atopic, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema, Atopic
- What is being tested?
- 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Nov 2021to 30 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
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.
- Conditions
- Eczema, Atopic
- Being tested
- 1.5% Palmitoylethanolamide (PEA) sold as Levagen+, Placebo Comparator
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% Palmitoylethanolamide (PEA) sold as Levagen+Drug
Also called PEA, Levagen+
A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area.
Placebo ComparatorDrug
Also called Moisturising cream
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.
| Study group | Role | What they receive |
|---|---|---|
| 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ | Experimental | 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. Receives: Drug: 1.5% Palmitoylethanolamide (PEA) sold as 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. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema area and severity index (SA-EASI)
Change in eczema area and severity index (SA-EASI)
Measured: Baseline prior to commencement, Week 2 and Week 4
Secondary outcomes (4)
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.
Measured: Baseline prior to commencement, Week 2 and Week 4
Change in topical anti-inflammatory use
Change in self-reported topical anti-inflammatory use
Measured: Baseline prior to commencement, Week 2 and Week 4
Patient eczema self assessment (Patient Orientated Eczema Measure)
Improvement in POEM. Minimum value 0 - clear or almost clear, Maximum value 28 - Very severe eczema
Measured: Baseline prior to commencement, Week 2 and Week 4
Change in Quality of Life (DQOL)
Change in quality of life questionnaire scores
Measured: Baseline prior to commencement, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start29 Nov 2021
- Primary completion3 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eczema, AtopicStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Briskey, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003453
- Sponsor's protocol ID
- PEA-XMA-20
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
Rao A, Moussa AA, Erickson J, Briskey D. Efficacy of Topical Palmitoylethanolamide (Levagen+) for the Management of Eczema Symptoms: A Double-Blind, Comparator-Controlled, Randomized Clinical Trial. Skin Pharmacol Physiol. 2023;36(6):288-295. doi: 10.1159/000536670. Epub 2024 Feb 26.
PubMed 38408443
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
- ClinicalTrials.gov ID
- NCT05003453
- Acronym / sponsor ID
- PEA-XMA-20
- Conditions
- Eczema, Atopic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ | Experimental | Drug: 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. |
| Placebo comparator | Placebo comparator | Drug: Placebo ComparatorA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5% Palmitoylethanolamide (PEA) sold as Levagen+Also: PEA, Levagen+A topical cream containing 1.5% PEA applied to the affected site 2-times daily, liberally to coat and cover affected area. | Drug | 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ |
| Placebo ComparatorAlso: Moisturising creamA 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. | Drug | Placebo comparator |
Primary outcome
Eczema area and severity index (SA-EASI)
Time frame: Baseline prior to commencement, Week 2 and Week 4
Change in eczema area and severity index (SA-EASI)
4 secondary outcomes
Change in itchiness (pruritus numerical rating scale)
Time frame: Baseline prior to commencement, Week 2 and Week 4
Change in topical anti-inflammatory use
Time frame: Baseline prior to commencement, Week 2 and Week 4
Patient eczema self assessment (Patient Orientated Eczema Measure)
Time frame: Baseline prior to commencement, Week 2 and Week 4
Change in Quality of Life (DQOL)
Time frame: Baseline prior to commencement, Week 2 and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38408443Rao A, Moussa AA, Erickson J, Briskey D. Efficacy of Topical Palmitoylethanolamide (Levagen+) for the Management of Eczema Symptoms: A Double-Blind, Comparator-Controlled, Randomized Clinical Trial. Skin Pharmacol Physiol. 2023;36(6):288-295. doi: 10.1159/000536670. Epub 2024 Feb 26.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Briskey, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ in people with Eczema, Atopic, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema area and severity index (SA-EASI) (time frame: Baseline prior to commencement, Week 2 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.