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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05003453




Registration number
NCT05003453
Ethics application status
Date submitted
6/08/2021
Date registered
12/08/2021
Date last updated
18/11/2023

Titles & IDs
Public title
The Effectiveness of a Topical Palmitoylethanolamide (PEA) Formulation (Levagen+) for Reducing Symptoms of Eczema
Scientific title
The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
Secondary ID [1] 0 0
PEA-XMA-20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema, Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Treatment: Drugs - Placebo Comparator

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Eczema area and severity index (SA-EASI)
Timepoint [1] 0 0
Baseline prior to commencement, Week 2 and Week 4
Secondary outcome [1] 0 0
Change in itchiness (pruritus numerical rating scale)
Timepoint [1] 0 0
Baseline prior to commencement, Week 2 and Week 4
Secondary outcome [2] 0 0
Change in topical anti-inflammatory use
Timepoint [2] 0 0
Baseline prior to commencement, Week 2 and Week 4
Secondary outcome [3] 0 0
Patient eczema self assessment (Patient Orientated Eczema Measure)
Timepoint [3] 0 0
Baseline prior to commencement, Week 2 and Week 4
Secondary outcome [4] 0 0
Change in Quality of Life (DQOL)
Timepoint [4] 0 0
Baseline prior to commencement, Week 2 and Week 4

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Global Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05003453
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Briskey, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05003453