ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001096842

Ethics application status

Approved

Date submitted

20/07/2021

Date registered

18/08/2021

Date last updated

31/08/2023

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]

MBS02

Universal Trial Number (UTN)

U1111-1266-6526

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Eczema

Condition category

Condition code

Skin

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]

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]

Difference in Patient Orientated Eczema Measure (POEM) scores

Timepoint [1]

Baseline, Week 6 post-intervention commencement

Secondary outcome [1]

Proportion of participants with a >=4 change in POEM score compared to baseline

Timepoint [1]

Baseline, Week 6 post-intervention commencement

Secondary outcome [2]

Difference in Patient Orientated Scoring Atopic Dermatitis (PO_SCORAD) score between groups

Timepoint [2]

Baseline, Week 6 post-intervention commencement

Secondary outcome [3]

Proportions of withdrawals for worsening eczema between groups, assessed by audit of study database.

Timepoint [3]

Week 6 post-intervention commencement

Secondary outcome [4]

Absolute change in Dermatology Life Quality Index (DLQI) score compared to baseline.

Timepoint [4]

Baseline, Week 6 post-intervention commencement

Secondary outcome [5]

Patient acceptability of treatment as assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Version II

Timepoint [5]

Week 6 post-intervention commencement

Secondary outcome [6]

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]

Week 6 Post-intervention commencement

Secondary outcome [7]

Comparison of intensity SCORAD scores (Part B) between blinded pharmacists.

Timepoint [7]

Week 6 Post-intervention commencement

Secondary outcome [8]

Proportions of protocol violating treatment escalations between groups based on participant self-report

Timepoint [8]

Weekly up to week 6 post-intervention commencement.

Secondary outcome [9]

Numerical Rating Scale score for the acceptability of ECMT-154 for the treatment of eczmea (1 unacceptable to 10 acceptable)

Timepoint [9]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

24/12/2021

Actual

20/01/2022

Date of last participant enrolment

Anticipated

20/07/2023

Actual

22/05/2023

Date of last data collection

Anticipated

14/09/2023

Actual

20/07/2023

Sample size

Target

118

Accrual to date

Final

118

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Manuka Biosciences

Address [1]

Manuka Biosciences
300 Richmond Road,
Grey Lynn, Auckland, 1021

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee (HDEC)

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/08/2021

Approval date [1]

03/12/2021

Ethics approval number [1]

2021 EXP 11490

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

Dr Gabby Shortt

Address

Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021

Country

New Zealand

Phone

+64 4 805 0261

Fax

gabby.shortt@mrinz.ac.nz

Contact person for public queries

Name

Gabby Shortt

Address

Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021

Country

New Zealand

Phone

+64 4 805 0261

Fax

gabby.shortt@mrinz.ac.nz

Contact person for scientific queries

Name

Gabby Shortt

Address

Medical Research Institute of New Zealand,
Level 7 Clinical Services Building,
Wellington Hospital,
Riddiford Street, Newtown
Wellington, 6021

Country

New Zealand

Phone

+64 4 805 0261

Fax

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Manuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand.	2024	https://dx.doi.org/10.1186/s12906-024-04358-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically