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Trial registered on ANZCTR


Registration number
ACTRN12614000004662
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
2/01/2014
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-blind randomised controlled trial of topical Kanuka honey for the treatment of Rosacea
Scientific title
In adult patients with rosacea will topical medical grade Kanuka honey reduce rosacea severity compared with Cetomacrogol control cream.
Secondary ID [1] 283429 0
None
Universal Trial Number (UTN)
U1111-1146-6857
Trial acronym
KH06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rosacea 290344 0
Condition category
Condition code
Skin 290739 290739 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade Kanuka honey with 10% glycerin content applied to the affected facial area twice daily for 30-60 minutes per application, for eight weeks. A patient diary will record applications during the treatment period.
Intervention code [1] 288152 0
Treatment: Other
Comparator / control treatment
The control cream Cetomacrogol applied to the affected facial area twice daily for 30-60 minutes per application, for eight weeks. Kanuka honey will not be used by the control group. Cetomacrogol is a liquid paraffin and white soft paraffin topical emollient, made up of water, petrolatum, Cetearyl Alcohol, mineral oil, Ceteth-20, p-Chloro-m-Cresol.
Control group
Active

Outcomes
Primary outcome [1] 290741 0
The proportion of subjects who have a 2 or greater improvement in Investigator-rated 7 point Rosacea Severity Score (RSS)
Timepoint [1] 290741 0
At baseline and Week 8 visits
Secondary outcome [1] 305137 0
Change in subject-rated Rosacea related quality of life (utilising the Dermatology Quality of Life Index [DLQI])
Timepoint [1] 305137 0
At baseline, Week 2, and Week 8 visits
Secondary outcome [2] 305138 0
Subject-rated global Rosacea improvement using a Visual Analogue Score (VAS)
Timepoint [2] 305138 0
At Week 2 and Week 8 visits
Secondary outcome [3] 305139 0
Change in subject-related global Rosacea severity using Visual Analogue Score (VAS)
Timepoint [3] 305139 0
At baseline and Week 2 visits
Secondary outcome [4] 305140 0
Change in Investigator-rated 7 point Rosacea Severity Score (RSS)
Timepoint [4] 305140 0
At baseline, Week 2 and Week 8 visits
Secondary outcome [5] 305141 0
Daily self-reported use (applications per day)
Timepoint [5] 305141 0
Daily for 8 weeks
Secondary outcome [6] 305142 0
Weekly self-reported global Rosacea severity (VAS scale)
Timepoint [6] 305142 0
Weekly for 8 weeks
Secondary outcome [7] 310089 0
Withdrawals due to worsening of rosacea
Timepoint [7] 310089 0
At the point of withdrawal

Eligibility
Key inclusion criteria
Aged 16 or over at the time of enrolment
Baseline facial Rosacea Severity Score (RSS) of 2 or greater
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for systemic corticosteroids, or systemic corticosteroid treatment in the 4 weeks prior to Visit 1 Current requirement for oral or topical antibiotic therapy for rosacea Current requirement for topical corticosteroid treatment for rosacea Known or suspected allergy to honey, or Cetomacrogol control cream Any other condition which, at the investigator's discretion, it is believed may present a safety risk or impact the feasibility of the study or the study results

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)
Eligible patients will be randomised into the study. Treatment allocation will be randomised in a 1:1 ratio to receive either application of topical Kanuka honey cream twice daily or application of topical Cetomacrogol control cream twice daily. Randomisation envelopes will contain details of treatment allocation per patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biostatistitian to generate randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Subjects and study site staff will not be blinded to the treatment allocation. An independent investigator at each site will remain blinded to the treatment allocation throughout the study and perform the RSS assessment.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We anticipate the proportion of participants in the control group who respond will be between 25 and 50%. A total of 124 participants (62 in each group) has 80% power at 5% significance to detect an absolute difference of 25% responders. Recruitment of 138 participants allows for a 10% drop-out rate.

Logistic regression will be used to test for the difference in response rates defined as the proportion of participants who have greater than or equal to two point improvement in the Investigator-rated Rosacea Severity score at week 8 compared to baseline.

The continuous secondary outcome variables will be analysed using ANOVA with baseline readings as a continuous co-variate. Daily self-reported use will be analysed by Poisson regression.

Recruitment
Recruitment status
Completed
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] 5529 0
New Zealand
State/province [1] 5529 0

Funding & Sponsors
Funding source category [1] 288149 0
Commercial sector/Industry
Name [1] 288149 0
Honeylab Ltd
Address [1] 288149 0
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country [1] 288149 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Honeylab Ltd
Address
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country
New Zealand
Secondary sponsor category [1] 286873 0
None
Name [1] 286873 0
Address [1] 286873 0
Country [1] 286873 0
Other collaborator category [1] 277662 0
Charities/Societies/Foundations
Name [1] 277662 0
Medical Research Institute of New Zealand
Address [1] 277662 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [1] 277662 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290067 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290067 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290067 0
New Zealand
Date submitted for ethics approval [1] 290067 0
15/08/2013
Approval date [1] 290067 0
16/10/2013
Ethics approval number [1] 290067 0
13/CEN/118

Summary
Brief summary
A recent pilot study investigating the use and acceptability of Kanuka honey in Rosacea showed a reduction in severity in 70% of subjects, therefore this study treatment has the potential to be an effective treatment for Rosacea symptoms. In this study 138 adults with Rosacea will apply either Kanuka honey or Cetomacrogol cream to areas of Rosacea on their face for 30-60 minutes twice a day for 8 weeks.

At baseline and after 2 weeks and 8 weeks the patient's Rosacea will be assessed to look at changes in severity. Participants will complete a diary for 8 weeks to record their daily treatment applications and weekly severity assessment. Subjects will complete a Dermatology Quality of Life questionnaire at all visits, to note any changes in quality of life. A visual analogue scale will be completed to note any improvement or worsening of a patient's rosacea at Visits 2 and 3.

This study will investigate the effectiveness of Kanuka honey in treating rosacea, potentially improving the health outcomes of those with the condition, and will contribute to the knowledge base around the use of honey for the treatment of skin conditions.
Trial website
Trial related presentations / publications
Braithwaite I, Hunt A, Riley J, et al. Randomised controlled trial of topical kanuka honey for the treatment of rosacea. BMJ Open 2015;5: e007651. doi:10.1136/ bmjopen-2015-007651
Public notes

Contacts
Principal investigator
Name 43774 0
Prof Richard Beasley
Address 43774 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43774 0
New Zealand
Phone 43774 0
+64 4 8050147
Fax 43774 0
+64 4 3895707
Email 43774 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 43775 0
Mrs Anna Hunt
Address 43775 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43775 0
New Zealand
Phone 43775 0
+64 4 8050147
Fax 43775 0
+64 4 3895707
Email 43775 0
anna.hunt@mrinz.ac.nz
Contact person for scientific queries
Name 43776 0
Mrs Anna Hunt
Address 43776 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43776 0
New Zealand
Phone 43776 0
+64 4 8050147
Fax 43776 0
+64 4 3895707
Email 43776 0
anna.hunt@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary