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Trial registered on ANZCTR


Registration number
ACTRN12614000002684
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
2/01/2014
Date last updated
4/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-blind randomised controlled trial of topical Kanuka honey for the treatment of Nappy Rash
Scientific title
In children less than 5 years old with nappy rash will topical medical grade Kanuka honey reduce nappy rash severity compared with Bepanthen Nappy Rash Ointment, and is it acceptable to parents/caregivers.
Secondary ID [1] 283476 0
None
Universal Trial Number (UTN)
U1111-1146-7495
Trial acronym
KH08
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nappy Rash 290396 0
Condition category
Condition code
Skin 290787 290787 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 area at each nappy change for two weeks. There is no protocol-defined time for how long honey is applied at each nappy change. The applied honey will remain in place until the next nappy change. A patient diary will record applications during the treatment period.
Intervention code [1] 288190 0
Treatment: Other
Comparator / control treatment
The control cream Bepanthen Nappy Rash Ointment applied to the affected area at each nappy change for two weeks. Kanuka honey will not be used by the control group. Bepanthen Nappy Rash Ointment contains dexpanthenol (Vitamin B5) 50mg/g
Control group
Active

Outcomes
Primary outcome [1] 290783 0
Nappy rash severity score (NRSS) of 1 or greater
Timepoint [1] 290783 0
Week 2 visit
Secondary outcome [1] 305279 0
Mean NRSS
Timepoint [1] 305279 0
At baseline and Week 2 visits
Secondary outcome [2] 305280 0
Mean parent/caregiver-rated severity using Visual Analogue Score (VAS)
Timepoint [2] 305280 0
At baseline and Week 2 visits
Secondary outcome [3] 305281 0
Parent/caregiver-rated acceptability using Visual Analogue Score (VAS)
Timepoint [3] 305281 0
Week 2 visit
Secondary outcome [4] 305282 0
Parent/Caregiver reported use (mean applications per day)
Timepoint [4] 305282 0
Daily for 2 weeks
Secondary outcome [5] 305283 0
Daily parent/caregiver reported severity (VAS)
Timepoint [5] 305283 0
Daily for 2 weeks

Eligibility
Key inclusion criteria
Aged less than 5 years old at the time of enrolment
Doctor’s diagnosis of nappy rash
Nappy Rash Severity Score of 2 or greater
Minimum age
0 Years
Maximum age
4 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current requirement for systemic corticosteroid, systemic anti-fungal or systemic antibiotic treatment, or has had systemic corticosteroid, systemic anti-fungal or systemic antibiotic treatment within 4 weeks prior to Visit 1
Current requirement for topical corticosteroid, topical anti-fungal or topical antibiotic treatment for Nappy Rash
Known or suspected allergy to honey or Bepanthen Nappy Rash Ointment
Any other condition which, at the investigators discretion, it is believed may present a safety risk or impact on 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 at each nappy change or application of topical Bepanthen Nappy Rash Ointment at each nappy change. 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, parents/caregivers, 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 NRSS 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 a Nappy Rash severity score of less than or equal to one at week 2 compared to baseline.

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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
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] 5545 0
New Zealand
State/province [1] 5545 0

Funding & Sponsors
Funding source category [1] 288185 0
Commercial sector/Industry
Name [1] 288185 0
Honeylab Ltd
Address [1] 288185 0
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country [1] 288185 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] 286910 0
None
Name [1] 286910 0
Address [1] 286910 0
Country [1] 286910 0
Other collaborator category [1] 277669 0
Charities/Societies/Foundations
Name [1] 277669 0
Medical Research Institute of New Zealand
Address [1] 277669 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [1] 277669 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290094 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290094 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290094 0
New Zealand
Date submitted for ethics approval [1] 290094 0
15/08/2013
Approval date [1] 290094 0
16/10/2013
Ethics approval number [1] 290094 0
13/CEN/120

Summary
Brief summary
A recent non-controlled pilot study of the acceptability and feasibility of topical medical grade Kanuka honey for the treatment of Nappy Rash has shown the honey to be an acceptable and potentially effective treatment with a reduction in investigator-rated severity in 60% of participants, therefore this study treatment has the potential to be an effective treatment for Nappy Rash symptoms. In this study 138 children under 5 years of age with Nappy Rash will have applied either Kanuka honey or Bepanthen Nappy Rash Ointment to areas of Nappy Rash at every nappy change for 2 weeks.

At baseline and after 2 weeks the patient's Nappy Rash will be assessed to look at changes in severity. At Week 2 visit parent/caregiver acceptability will also be assessed. Participants' parents/caregivers will complete a diary for 2 weeks to record the daily treatment applications and daily severity assessment.

This study will investigate the effectiveness of Kanuka honey in treating nappy rash, 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
Public notes

Contacts
Principal investigator
Name 43942 0
Prof Richard Beasley
Address 43942 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43942 0
New Zealand
Phone 43942 0
+64 4 8050147
Fax 43942 0
+64 4 3895707
Email 43942 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 43943 0
Mrs Anna Hunt
Address 43943 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43943 0
New Zealand
Phone 43943 0
+64 4 8050147
Fax 43943 0
+64 4 3895707
Email 43943 0
anna.hunt@mrinz.ac.nz
Contact person for scientific queries
Name 43944 0
Mrs Anna Hunt
Address 43944 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43944 0
New Zealand
Phone 43944 0
+64 4 8050147
Fax 43944 0
+64 4 3895707
Email 43944 0
anna.hunt@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results