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.
Honeylab Ltd
950 participants
Sep 10, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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.
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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.
Locations(1)
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ACTRN12615000648527