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Trial registered on ANZCTR


Registration number
ACTRN12618001754235
Ethics application status
Approved
Date submitted
19/10/2018
Date registered
25/10/2018
Date last updated
25/07/2019
Date data sharing statement initially provided
21/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
3% Kanuka Oil Cream for the Topical Treatment of Eczema
Scientific title
Randomised Controlled Trial of 3% Kanuka Oil Cream vs Vehicle Control for the Topical Treatment of Eczema
Secondary ID [1] 296354 0
HK1
Secondary ID [2] 296355 0
MRINZ/18/04
Universal Trial Number (UTN)
U1111-1215-3157
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Eczema 310082 0
Condition category
Condition code
Skin 308830 308830 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3% Kanuka Oil Cream
Applied topically, twice daily, for six weeks.
The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally tot he affected areas.
A weekly participant diary will be used to monitor adherence.
Intervention code [1] 312687 0
Treatment: Drugs
Comparator / control treatment
Vehicle Control
The same cream as the active intervention without the kanuka oil.
Composition: Prunus Amygdalus Dulcis (Almond) Oil, Kunzea Ericoides (Kanuka) Oil, Glycerine, Cetearyl Alcohol, Cetearyl Glucoside, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Dehydroacetic Acid

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

Outcomes
Primary outcome [1] 307804 0
Difference in POEM scores
Timepoint [1] 307804 0
Week 6 post-baseline
Secondary outcome [1] 352970 0
Proportion of participants with a >=4 improvement in POEM score compared to baseline.
Timepoint [1] 352970 0
Week 6 post-baseline
Secondary outcome [2] 352971 0
Difference in PO-SCORAD score between groups
Timepoint [2] 352971 0
Week 6 post-baseline
Secondary outcome [3] 352972 0
Proportions of withdrawals for worsening eczema between groups.

At the point of withdrawal participants will be asked if a reason they are withdrawing is worsening of their eczema. The proportions of participants that respond in the affirmative will be compared between groups.
Timepoint [3] 352972 0
Assessed at the point of participant withdrawal from the study
Secondary outcome [4] 352973 0
Absolute change in DLQI score compared to baseline.
Timepoint [4] 352973 0
Week 6 post-baseline
Secondary outcome [5] 352974 0
Patient acceptability of treatment as assessed by TSQM Version 2.
Timepoint [5] 352974 0
Week 6 post-baseline
Secondary outcome [6] 352975 0
Proportions of related and probably related cutaneous and systemic adverse events between treatment groups. eg worsening eczema, local inflammation. or allergic cutaneous reactions.

Adverse events will be assessed for relation to the study treatment by they study doctor. All adverse events deemed related or probably related will be included in the proportions.
Timepoint [6] 352975 0
Week 6 post-baseline
Secondary outcome [7] 352976 0
Comparison of intensity SCORAD scores (Part B) between blinded pharmacists.
Timepoint [7] 352976 0
Week 6 post-baseline
Secondary outcome [8] 352977 0
Comparison of intensity SCORAD scores (Part B) between blinded pharmacists and a blinded dermatologist.
Timepoint [8] 352977 0
Week 6 post-baseline

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)
Randomisation will be done in the study database using the inbuilt randomisation module. Investigators will not have access to the randomisation schedule.
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on a minimum clinically important difference (MCID) of 3.4 and standard deviation (SD) of 4.8 for the change in POEM score, each treatment group would require 32 participants. Accounting for an assumed dropout rate of 20% in such a community-based study, 40 participants would be required per arm (80 total) having 80% power at 5% two-sided alpha.

Recruitment
Recruitment status
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] 20939 0
New Zealand
State/province [1] 20939 0

Funding & Sponsors
Funding source category [1] 300958 0
Other
Name [1] 300958 0
Hikurangi Bioactives Limited Partnership
Address [1] 300958 0
6434 Waiapu Road, RD 1, Ruatoria 4081
Country [1] 300958 0
New Zealand
Primary sponsor type
Other
Name
Hikurangi Bioactives Limited Partnership
Address
6434 Waiapu Road, RD 1, Ruatoria 4081
Country
New Zealand
Secondary sponsor category [1] 300530 0
None
Name [1] 300530 0
Address [1] 300530 0
Country [1] 300530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301723 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 301723 0
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 301723 0
New Zealand
Date submitted for ethics approval [1] 301723 0
16/08/2018
Approval date [1] 301723 0
05/11/2018
Ethics approval number [1] 301723 0
18/CEN/152

Summary
Brief summary
This study will assess the efficacy of 3% Kanuka Oil cream in the treatment of eczema.
The study is designed as a single blind, randomised, vehicle controlled study. 80 participants will be recruited via pharmacies throughout New Zealand and will be randomised 1:1 to receive either 3% Kanuka Oil cream or vehicle control.
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. A paper diary will be offered as a back-up if participants are unable to complete the electronic diary. The paper diary will be returned at the final study visit.
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 study treatment.
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 87890 0
Dr Alex Semprini
Address 87890 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 87890 0
New Zealand
Phone 87890 0
+64 4 805 0260
Fax 87890 0
Email 87890 0
alex.semprini@mrinz.ac.nz
Contact person for public queries
Name 87891 0
Mr Nick Shortt
Address 87891 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 87891 0
New Zealand
Phone 87891 0
+64 4 805 0236
Fax 87891 0
Email 87891 0
nick.shortt@mrinz.ac.nz
Contact person for scientific queries
Name 87892 0
Mr Nick Shortt
Address 87892 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
New Zealand
Country 87892 0
New Zealand
Phone 87892 0
+64 4 805 0236
Fax 87892 0
Email 87892 0
nick.shortt@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has yet to be decided
What supporting documents are/will be available?
No other documents available
Summary results
No Results