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Trial registered on ANZCTR


Registration number
ACTRN12612000565842
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 Rosacea
Scientific title
In adult patients with rosacea is topical medical-grade honey acceptable and does it appear to reduce the severity of rosacea?
Secondary ID [1] 280396 0
None
Universal Trial Number (UTN)
U1111-1130-2264
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rosacea 286375 0
Condition category
Condition code
Skin 286617 286617 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade honey applied to rosacea for 30-60 minutes twice daily for 2 weeks. The subject will apply a sufficient amount of honey to create a thin film over the affected area on their face.
Intervention code [1] 284873 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287030 0
Rosacea severity assessed by Rosacea severity index
Timepoint [1] 287030 0
At baseline and at final visit after 2 weeks
Secondary outcome [1] 297244 0
Subjective assessment of rosacea severity, measured by visual analogue score (VAS)
Timepoint [1] 297244 0
At baseline and at final visit after 2 weeks
Secondary outcome [2] 297245 0
Acceptability of honey therapy, measured by VAS
Timepoint [2] 297245 0
At baseline and at final visit after 2 weeks

Eligibility
Key inclusion criteria
Aged 16 or over at the time of enrolment
Roasacea involving the upper or lower limbs
Bilateral lesions, to allow comparison
Minimum age
16 Years
Maximum age
No limit
Sex
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
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
1/06/2012
Actual
11/07/2012
Date of last participant enrolment
Anticipated
Actual
31/10/2012
Date of last data collection
Anticipated
Actual
14/11/2012
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4282 0
New Zealand
State/province [1] 4282 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 285163 0
Commercial sector/Industry
Name [1] 285163 0
Honeylab Ltd
Country [1] 285163 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] 284027 0
None
Name [1] 284027 0
Address [1] 284027 0
Country [1] 284027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300609 0
Multi-region Ethics Committee
Ethics committee address [1] 300609 0
Ethics committee country [1] 300609 0
New Zealand
Date submitted for ethics approval [1] 300609 0
11/04/2012
Approval date [1] 300609 0
30/04/2012
Ethics approval number [1] 300609 0
MEC/12/03/025

Summary
Brief summary
There are reasons to believe that medical grade-honey applied directly to skin may be an effective treatment for rosacea. In this study 10 adults with rosacea will apply honey to their face for 30-60 minutes twice daily for 2 weeks.

After two weeks the rosacea 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 rosacea. 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 rosacea
James Fingleton Davitt Sheahan Nicola Cave Alexander Brinded Mark Weatherall Kyle Perrin Richard Beasley
First published: 11 September 2013 https://doi.org/10.1111/fct.12057
Public notes

Contacts
Principal investigator
Name 34114 0
Dr James Fingleton
Address 34114 0
Medical Research Institute of New Zealand Private Bag 7902 Wellington 6242
Country 34114 0
New Zealand
Phone 34114 0
+6448051047
Fax 34114 0
Email 34114 0
[email protected]
Contact person for public queries
Name 17361 0
James Fingleton
Address 17361 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17361 0
New Zealand
Phone 17361 0
+6448050147
Fax 17361 0
Email 17361 0
[email protected]
Contact person for scientific queries
Name 8289 0
James Fingleton
Address 8289 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8289 0
New Zealand
Phone 8289 0
+6448050147
Fax 8289 0
Email 8289 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.