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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000648527

Acronym

KH10

Enrollment

952

Registered

2015-06-23

Start date

2015-09-10

Completion date

2017-12-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

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.

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.

Outcome results