The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000563864
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
25/05/2012
Date last updated
7/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Topical Honey for the Treatment of
Nappy Rash
Scientific title
In children less than 5 yrs old with nappy rash is topical medical-grade honey acceptable and does it appear to reduce the severity of nappy rash?
Secondary ID [1] 280392 0
None
Universal Trial Number (UTN)
U1111-1130-2145
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nappy Rash 286372 0
Condition category
Condition code
Skin 286614 286614 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade honey applied to nappy rash in a thin film sufficient to cover the affected area, at each nappy change for 2 weeks.
Intervention code [1] 284875 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287026 0
Nappy rash severity assessed by a 5 point nappy rash severity score.
Timepoint [1] 287026 0
At baseline and at final visit after 2 weeks
Secondary outcome [1] 297232 0
Subjective assessment of nappy rash severity, measured by visual analogue score (VAS)
Timepoint [1] 297232 0
At baseline and at final visit after 2 weeks
Secondary outcome [2] 297233 0
Objective assessment of global nappy rash severity, measured by VAS
Timepoint [2] 297233 0
At baseline and at final visit after 2 weeks
Secondary outcome [3] 297234 0
Acceptability of honey therapy, measured by VAS
Timepoint [3] 297234 0
At final visit after 2 weeks

Eligibility
Key inclusion criteria
Aged <5 at the time of enrolment
Doctors diagnosis of nappy rash
Minimum age
No limit
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for topical or systemic corticosteroids, as judged by treating doctor
Requirement for antibiotic therapy, as judged by treating doctor
Known or suspected allergy to honey or dressings
Any other condition which, at the investigators 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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] 4280 0
New Zealand
State/province [1] 4280 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 285159 0
Commercial sector/Industry
Name [1] 285159 0
Honeylab Ltd
Address [1] 285159 0
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country [1] 285159 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 284022 0
None
Name [1] 284022 0
Address [1] 284022 0
Country [1] 284022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300611 0
Multi-region ethics committee
Ethics committee address [1] 300611 0
Ethics committee country [1] 300611 0
New Zealand
Date submitted for ethics approval [1] 300611 0
11/04/2012
Approval date [1] 300611 0
30/04/2012
Ethics approval number [1] 300611 0
MEC/12/03/023

Summary
Brief summary
There are reasons to believe that medical grade-honey applied directly to skin may be an effective treatment for nappy rash. In this study parents/guardians of 10 children with nappy rash will apply medical grade honey to the napkin area at each nappy change.

After two weeks the nappy rash will be assessed to look at changes in severity. Participants will also be asked about their experience of using honey.

This trial will provide useful information on the practicalities of topical honey as a treatment for nappy rash. It will also give an initial signal as to whether honey may be effective.
Trial website
Trial related presentations / publications
Topical kanuka honey for the treatment of nappy rash
James Fingleton Christopher Tofield Colin Helm Andrew Corin Mark Weatherall Richard Beasley
First published: 06 January 2014 https://doi.org/10.1111/fct.12078
Public notes

Contacts
Principal investigator
Name 34111 0
Dr James Fingleton
Address 34111 0
Medical Research Institute of New Zealand Private Bag 7902 Wellington 6242
Country 34111 0
New Zealand
Phone 34111 0
+6448051047
Fax 34111 0
Email 34111 0
james.fingleton@mrinz.ac.nz
Contact person for public queries
Name 17358 0
Dr James Fingleton
Address 17358 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17358 0
New Zealand
Phone 17358 0
+6448050147
Fax 17358 0
Email 17358 0
James.Fingleton@mrinz.ac.nz
Contact person for scientific queries
Name 8286 0
Dr James Fingleton
Address 8286 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8286 0
New Zealand
Phone 8286 0
+6448050147
Fax 8286 0
Email 8286 0
James.Fingleton@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