ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000648527

Ethics application status

Approved

Date submitted

10/06/2015

Date registered

23/06/2015

Date last updated

22/02/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

5% Aciclovir or Honevo(Trademark) as a treatment for cold sores

Scientific title

In adult patients with cold sores will topical medical grade honey reduce healing time compared to topical 5% aciclovir alone.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1170-1537

Trial acronym

KH10

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Herpes Labialis

Condition category

Condition code

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Topical medical grade Kanuka honey applied to the affected area five times daily for fourteen days or until skin returns to normal, whichever is sooner. A participant diary will record applications during the treatment period.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Standard treatment is 5% topical aciclovir cream. Participants in the control arm will apply 5% topical aciclovir to the affected area five times daily for fourteen days or until the skin returns to normal.

Control group

Active

Outcomes

Primary outcome [1]

Healing time (from randomization to the return to normal skin) as measured daily by participant reported cold sore stage from a pictorial chart.

Timepoint [1]

Daily up to fourteen days.

Secondary outcome [1]

Total healing time, defined as the time from development of first sign or symptom to the return to normal skin, as measured daily by participant reported cold sore stage from a pictorial chart.

Timepoint [1]

Daily up to fourteen days.

Secondary outcome [2]

Total healing time stratified by stage of the lesion at onset of treatment, as measured daily by participant reported cold sore stage from a pictorial chart.

Timepoint [2]

Daily up to fourteen days.

Secondary outcome [3]

Highest pain severity as recorded daily by participants using the scale 'o - 10' with 0 being no pain and 10 being most pain.

Timepoint [3]

Daily up to fourteen days.

Secondary outcome [4]

Time to pain resolution (defined as the time from first experiencing pain to total resolution of pain), as recorded daily by participants using the scale '0 - 10' with 0 being no pain and 10 being most pain.

Timepoint [4]

Daily up to fourteen days.

Secondary outcome [5]

Time to stage 4 from randomisation, as measured daily by participant reported cold sore stage from a pictorial chart.

Timepoint [5]

Daily up to fourteen days

Secondary outcome [6]

Time to stage 7 from stage 4, as measured daily by participant reported cold sore stage from a pictorial chart.

Timepoint [6]

Daily up to fourteen days

Secondary outcome [7]

Acceptability of treatments as measured by a numerical rating scale.

Timepoint [7]

At study follow up between day 15 and 35, on completion.

Eligibility

Key inclusion criteria

Aged 16 years or over at the time of enrolment.
Presentation to a pharmacy for treatment of a cold sore.
First cold sore symptoms (including prodromal symptoms e.g. tingling/pain) within 72 hours.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Any participant who is pregnant or breastfeeding.
Known or suspected allergy to honey, bees, aciclovir and/or glycerin.
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.
Patient has used oral aciclovir or other antiviral medicine, or any topical treatment, medical or complementary, on the current sore.
Participants planning to take or use any concomitant medications, which in the opinion of the investigator, could affect the cold sore during the course of the trial. This includes any topical product, medical or complementary, on the cold sore, oral aciclovir or other antiviral medicine, oral complementary medicines for cold sores, such as lysine supplements.

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 participants will be randomised into the study in a 1:1 ratio, one arm receiving topical medical grade Kanuka honey and the second arm receiving topical 5% aciclovir. Both groups will apply their specific treatment five times a day. Each pharmacy site will be provided an allocation of randomised patient packs containing the treatment allocation and patient diary. Pharmacists will dispense the appropriate treatment as randomised to the participant upon opening of the concealed envelope.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Biostatistitian to generate randomisation schedule.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Participants and study site staff will not be blinded to the allocated treatment due to the nature of the investigational product. Data analysis will be conducted by a statistician blinded to the allocation.

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Assuming that the median control duration of symptoms is five days and looking to achieve a one day median difference, with associated Hazard ratio of 1.25, 423 participants would be needed per arm of treatment, therefore the total required is 846. As this is a short study lasting only for the duration of one cold sore episode, then drop-outs from the study should be low, and so assuming that the drop-out rate is around 10%, then 950 participants will be randomized. This study size is consistent with similar 2-arm or 3-arm cold sore studies have required around 300-350 patients per treatment arm. Kaplan-Meier survival plots and estimates of median healing times and Cox Proportional Hazards with a random effect for participants to take into account the parallel design, compared time to healing and pain duration between treatments. Paired t-tests will be used to compare the continuous variables.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/07/2015

Actual

10/09/2015

Date of last participant enrolment

Anticipated

20/12/2017

Actual

20/12/2017

Date of last data collection

Anticipated

Actual

15/01/2018

Sample size

Target

950

Accrual to date

Final

952

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Honeylab Ltd

Address [1]

HoneyLab Ltd
Queens Wharf Business Centre
PO Box 10-799
Wellington, 6011

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Honeylab Ltd

Address

HoneyLab Ltd
Queens Wharf Business Centre
PO Box 10-799
Wellington, 6011

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Medical Research Institute of New Zealand

Address [1]

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

09/06/2015

Ethics approval number [1]

15/NTB/93

Summary

Brief summary

A recent pilot study has shown that medical grade Kanuka honey is an acceptable treatment for cold sores. This large-scale randomised controlled trial has the potential to demonstrate a combination product of Kanuka honey and aciclovir (the current topical standard treatment) as an effective treatment for cold sores. In this study 950 participants seeking over the counter treatment for a cold sore will be randomised to receive either topical medical grade Kanuka honey or topical 5% aciclovir alone. Participants will apply their treatment five times a day for fourteen days or until the skin returns to normal, whichever is sooner. Participants will complete a paper or online diary recording the number of applications, the pain suffered that day and the stage of the cold sore based on a pictorial chart. At day fourteen each participant will receive a follow up telephone call to record adverse events and obtain narrative feedback.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/368118-HDEC Letter 15NTB93 Approved FULL Application with Non Standard Conditions.pdf

Contacts

Principal investigator

Name

Dr Irene Braithwaite

Address

Medical Research Institute of New Zealand Private Bag 7902 Wellington
6242

Country

New Zealand

Phone

+64 4 8050147

Fax

+64 4 3895707

irene.braithwaite@mrinz.ac.nz

Contact person for public queries

Name

Alex Semprini

Address

Medical Research Institute of New Zealand Private Bag 7902 Wellington
6242

Country

New Zealand

Phone

+648050260

Fax

+64 (0) 9 353 1800

coldsore@mrinz.ac.nz

Contact person for scientific queries

Name

Alex Semprini

Address

Medical Research Institute of New Zealand Private Bag 7902 Wellington
6242

Country

New Zealand

Phone

+64 4 8050147

Fax

+64 4 8050147

coldsore@mrinz.ac.nz

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

Source	Title	Year of Publication	DOI
Dimensions AI	Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting	2017	https://doi.org/10.1136/bmjopen-2017-017766
Embase	Kanuka honey versus aciclovir for the topical treatment of herpes simplex labialis: A randomised controlled trial.	2019	https://dx.doi.org/10.1136/bmjopen-2018-026201
Dimensions AI	Current landscape in antiviral drug development against herpes simplex virus infections	2022	https://doi.org/10.1002/smmd.20220004

N.B. These documents automatically identified may not have been verified by the study sponsor.

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