Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000564853
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
Cold Sores
Scientific title
In adult patients with cold sores is topical medical-grade honey acceptable and as good as or better than aciclovir for reducing the healing time?
Secondary ID [1] 280395 0
None
Universal Trial Number (UTN)
U1111-1130-2195
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold sores 286374 0
Condition category
Condition code
Skin 286616 286616 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade honey applied to lesion with an amount sufficient to cover the lesion in a thin film for 15mins, five times per day
Intervention code [1] 284874 0
Treatment: Other
Comparator / control treatment
Aciclovir applied to lesion with an amount sufficient to cover the lesion in a thin film for 15mins, five times per day.

Aciclovir is an anti-viral medication commonly applied to cold-sores to shorten the duration of cold-sores and resduce severity.
Control group
Active

Outcomes
Primary outcome [1] 287029 0
Healing time (defined as the time from development of first sign or symptom to the return to normal skin)
Timepoint [1] 287029 0
Daily diary kept by subject during an episode. Healing time derived from this.
Secondary outcome [1] 297242 0
Pain resolution (defined as the time from first experiencing pain to total resolution of pain)
Timepoint [1] 297242 0
Daily diary kept by subject during an episode. Outcome derived from this.
Secondary outcome [2] 297243 0
Pain severity
Timepoint [2] 297243 0
Daily diary kept by subject during an episode. Outcome derived from this.
Secondary outcome [3] 319204 0
Lesion severity
Timepoint [3] 319204 0
Daily diary kept by subject during an episode. Outcome derived from this.
Secondary outcome [4] 319205 0
Acceptability of the application of honey as measured by a visual analogue scale
Timepoint [4] 319205 0
At final visit

Eligibility
Key inclusion criteria
Aged 16 or over at the time of enrolment
At least two episodes of cold sores in the past 12 months
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known immune suppression or receiving medication likely to cause immune suppression
Requirement for systemic antiviral or antibiotic therapy, as judged by treating doctor
Known or suspected allergy to honey or acyclovir
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
Randomised controlled 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
30/06/2012
Date of last participant enrolment
Anticipated
Actual
12/09/2012
Date of last data collection
Anticipated
Actual
24/09/2013
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 4281 0
New Zealand
State/province [1] 4281 0
Wellington

Funding & Sponsors
Funding source category [1] 285161 0
Commercial sector/Industry
Name [1] 285161 0
Honeylab Ltd
Country [1] 285161 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] 284024 0
None
Name [1] 284024 0
Address [1] 284024 0
Country [1] 284024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293924 0
Multi-region Ethics Committee
Ethics committee address [1] 293924 0
c/- Ministry of Health
PO Box 5013
1 the Terrace
Wellington
Ethics committee country [1] 293924 0
New Zealand
Date submitted for ethics approval [1] 293924 0
Approval date [1] 293924 0
30/04/2012
Ethics approval number [1] 293924 0

Summary
Brief summary
There are reasons to believe that medical grade-honey applied directly to skin may be an effective treatment for cold sores. In this study 15 adults with recurrent cold sores will take part in a cross-over study comparing medical grade honey and topical aciclovir for the treatment of cold sores

When participants develop a cold sore they will start using the first allocated treatment on it for the duration of the lesion (maximum 2 weeks) and complete a subject diary. When participants develop a second cold sore they will use the second allocated treatment for the duration of the lesion (maximum 2 weeks) and complete a subject diary.

The sequesnce of honey then aciclovir or aciclovir then honey will be allocated randomly.

This trial will provide useful information on the practicalities of topical honey as a treatment for eczema. It will also give an initial signal as to whether honey may be effective.
Trial website
Trial related presentations / publications
Randomised controlled trial of topical kanuka honey for the treatment of cold sores
Fingleton, James et al.
Advances in Integrative Medicine , Volume 1 , Issue 3 , 119 - 123
DOI: http://dx.doi.org/10.1016/j.aimed.2014.09.001
Public notes

Contacts
Principal investigator
Name 34113 0
Dr James Fingleton
Address 34113 0
Medical Research Institute of New Zealand Private Bag 7902 Wellington 6242
Country 34113 0
New Zealand
Phone 34113 0
+6448050147
Fax 34113 0
Email 34113 0
[email protected]
Contact person for public queries
Name 17360 0
Dr James Fingleton
Address 17360 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17360 0
New Zealand
Phone 17360 0
+6448050147
Fax 17360 0
Email 17360 0
[email protected]
Contact person for scientific queries
Name 8288 0
Dr James Fingleton
Address 8288 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8288 0
New Zealand
Phone 8288 0
+6448050147
Fax 8288 0
Email 8288 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.