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Trial registered on ANZCTR


Registration number
ACTRN12621001096842p
Ethics application status
Submitted, not yet approved
Date submitted
20/07/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ECMT-154™ for the Topical Treatment of Eczema
Scientific title
Randomised Controlled Trial of ECMT-154™ vs Vehicle Control for the Topical Treatment of Eczema in Adults
Secondary ID [1] 304795 0
MBS02
Universal Trial Number (UTN)
U1111-1266-6526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 322862 0
Condition category
Condition code
Skin 320438 320438 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manuka-oil based 1% ECMT-154 cream
Applied topically, twice daily, for six weeks
The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally to the affected areas.
A weekly participant diary will be used to monitor adherence.
Intervention code [1] 321170 0
Treatment: Drugs
Comparator / control treatment
Vehicle Control
The same cream as the active intervention without the 1% ECMT-154
Composition: Propylene Glycol, Sodium lauryl sulfate, Stearyl alcohol, water, White soft paraffin, PEG 3350, PEG 300

Applied topically, twice daily, for six weeks.
The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally to the affected areas.
A weekly participant diary will be used to monitor adherence.
Control group
Placebo

Outcomes
Primary outcome [1] 328278 0
Difference in Patient Orientated Eczema Measure (POEM) scores
Timepoint [1] 328278 0
Baseline, Week 6 post-intervention commencement
Secondary outcome [1] 398327 0
Proportion of participants with a >=4 change in POEM score compared to baseline
Timepoint [1] 398327 0
Baseline, Week 6 post-intervention commencement
Secondary outcome [2] 398328 0
Difference in Patient Orientated Scoring Atopic Dermatitis (PO_SCORAD) score between groups
Timepoint [2] 398328 0
Baseline, Week 6 post-intervention commencement
Secondary outcome [3] 398330 0
Proportions of withdrawals for worsening eczema between groups, assessed by audit of study database.
Timepoint [3] 398330 0
Week 6 post-intervention commencement
Secondary outcome [4] 398331 0
Absolute change in Dermatology Life Quality Index (DLQI) score compared to baseline.
Timepoint [4] 398331 0
Baseline, Week 6 post-intervention commencement
Secondary outcome [5] 398332 0
Patient acceptability of treatment as assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Version II
Timepoint [5] 398332 0
Week 6 post-intervention commencement
Secondary outcome [6] 398333 0
Proportions of related and probably related adverse events between treatment groups. eg worsening eczema, local inflammation. or allergic cutaneous reactions, assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5)
Timepoint [6] 398333 0
Week 6 Post-intervention commencement
Secondary outcome [7] 398334 0
Comparison of intensity SCORAD scores (Part B) between blinded pharmacists.
Timepoint [7] 398334 0
Week 6 Post-intervention commencement
Secondary outcome [8] 398523 0
Proportions of protocol violating treatment escalations between groups based on participant self-report
Timepoint [8] 398523 0
Weekly up to week 6 post-intervention commencement.
Secondary outcome [9] 399851 0
Numerical Rating Scale score for the acceptability of Tripalma for the treatment of impetigo (1 unacceptable to 10 acceptable)
Timepoint [9] 399851 0
Week 6 post-intervention commencement

Eligibility
Key inclusion criteria
• Participant has the ability and willingness to sign a written informed consent using a digital signature or paper form if back up is required
• Participant is aged between 18 and 65 years of age, inclusive
• Participant reported, Physician diagnosis of eczema
• Participant has a POEM category score of ‘moderate or severe eczema’ (8 to 24)
• Participant is willing to stop all moisturisers and/or other skin barrier cream or emulsion treatments during the test period and replace with the investigational product assigned in this trial
• Participant is willing to replace their body wash and/or soaps with Aqueous cream as supplied at enrolment
• Participant is able and willing to attend the follow up visit during the visit window
• Participant is able and willing to complete the study and to comply with all study instructions
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current requirement for prescription of antibiotics or corticosteroids for the treatment of any condition (with the exception of inhaled corticosteroids)
• Use of antibiotics, corticosteroids, calceneurin inhibitors, or antihistamines within the last four weeks (with the exception of inhaled corticosteroids)
• Cutaneous mycotic or bacterial disease requiring a topical or systemic therapy
• Other skin condition which may affect the assessment of eczema severity
• History of allergy or hypersensitivity to the ingredients of the study treatments
• Participation in a clinical trial involving an investigational product during the last three months
• Participant is pregnant or planning to become pregnant during the study
• Any other condition which, at the investigators’ discretion, it is believed may present a safety risk or impact upon the ability of the participant to complete the study.

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)
Participants will be randomised in a 1:1 ratio to receive either the investigational product or active control. Randomisation will take place electronically within the REDCap CDMA, using the inbuilt randomisation module. Investigators will not have access to the randomisation schedule. Investigational product and active control will be dispensed in matching plain packaging.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician generated block randomisation schedule, using a block size of four
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis
Based on a minimum clinically important difference (MCID) of 3.4 and pooled standard deviation (SD) of 6.0 for the change in POEM score (HK1 study), each treatment group would require 50 participants for 80% power, 5% two-sided alpha. Allowing for 15% dropout, 60 participants would be required per arm (120 total).

Data will be analysed using STATA, SAS and/or SPSS software. p-value <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23971 0
New Zealand
State/province [1] 23971 0

Funding & Sponsors
Funding source category [1] 309167 0
Commercial sector/Industry
Name [1] 309167 0
Manuka Biosciences
Address [1] 309167 0
Manuka Biosciences
300 Richmond Road,
Grey Lynn, Auckland, 1021
Country [1] 309167 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Manuka Biosciences
Address
Manuka Biosciences
300 Richmond Road,
Grey Lynn, Auckland, 1021
Country
New Zealand
Secondary sponsor category [1] 310125 0
None
Name [1] 310125 0
Address [1] 310125 0
Country [1] 310125 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309029 0
Central Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 309029 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 309029 0
New Zealand
Date submitted for ethics approval [1] 309029 0
11/08/2021
Approval date [1] 309029 0
Ethics approval number [1] 309029 0

Summary
Brief summary
This study is a single blind, vehicle-controlled trial of 118 participants with moderate to severe eczema.

Participants will be recruited from community pharmacies by pharmacy staff. Pharmacy staff will be trained as investigators by a MRINZ investigator. The baseline visit will consist of screening, consent, demographics, eczema scoring, photo capture of a representative eczema lesion, randomisation and supply of study medication. Participants will be instructed to apply their treatment twice daily for six weeks.

Participants will complete a weekly electronic diary for five weeks. The electronic diaries will capture symptom scores, treatment compliance, and adverse events.
The participants will return to the pharmacy at the end of week six for a final study visit. The final visit will consist of eczema scoring, photo capture of a representative eczema lesion, treatment acceptability, adverse event collection, and concomitant medication collection.
A survey, two weeks after the final visit, will capture information about adverse events post intervention period.

The primary outcome for this study is improvement in patient-reported symptoms at six weeks. Secondary outcomes include improvement in patient-reported clinical signs, improvement in patient reported quality of life, and inter-rater validity of SCORAD (intensity section) between a blinded dermatologist and pharmacy investigators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112706 0
Dr Gabby Shortt
Address 112706 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 112706 0
New Zealand
Phone 112706 0
+64 4 805 0261
Fax 112706 0
Email 112706 0
gabby.shortt@mrinz.ac.nz
Contact person for public queries
Name 112707 0
Dr Gabby Shortt
Address 112707 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 112707 0
New Zealand
Phone 112707 0
+64 4 805 0261
Fax 112707 0
Email 112707 0
gabby.shortt@mrinz.ac.nz
Contact person for scientific queries
Name 112708 0
Dr Gabby Shortt
Address 112708 0
Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021
Country 112708 0
New Zealand
Phone 112708 0
+64 4 805 0261
Fax 112708 0
Email 112708 0
gabby.shortt@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results only.
When will data be available (start and end dates)?
Data will be available after the publication of the manuscript, no end date.
Available to whom?
Data will be available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For purposes of achieving specific aims outlined in the proposal.
How or where can data be obtained?
Proposals should be directed to Dr Gabby Shortt via email (gabby.shortt@mrinz.ac.nz)
What supporting documents are/will be available?
No other documents available
Summary results
No Results