Do you suffer from facial cold sores?
Can a natural topical cold sore treatment help treat facial cold sores?
Researchers at NICM Health Research Institute and the Medical Research Institute of New Zealand are looking for men and women aged 18 to 65 to join a clinical trial to find out if a single application, natural topical cold sore treatment helps reduce the duration and symptoms of facial cold sores.
Who can join?
- You are aged between 18 and 65.
- You currently live in Australia.
- You have had at least three previous outbreaks or episodes of cold sores.
- Have internet access on your mobile phone, tablet or computer.
- You do not need to currently have a cold sore to join the study.
The recruitment and administration of this trial is all done online and via phone to comply with all social distancing guidelines due to COVID-19. No face to face contact is required with any member of the research team.
- Screening via phone or zoom (10-minutes): In brief, after a telephone assessment and digital consent, if you are eligible you will be randomly allocated to one of two groups, either the active treatment or placebo. You are twice as likely to get the active treatment as the placebo treatment. You will receive your topical treatment by Australia Post courier service to your home or other location of your choice. Once it arrives you will be asked to upload a photo of the box that contains the treatment vial so we can ensure you have received the correct box and it is intact.
- First phone or zoom ‘visit’ (10-minutes): When you next get a cold sore you will need to contact the research team either via text message or email within 48 hours of the start of your cold sore. You will need to upload a photo of your cold sore which you can take via your cell phone, tablet or laptop camera. A member of the research team will contact you via phone as soon as possible, double check your eligibility to continue in the study, re-confirm your consent, and explain how to apply the treatment. Once you have applied the treatment you will need to return the rest of the vial (which may or may not be completely empty) to us via a pre-paid envelope.
- Daily diary (2 to 3-minutes per day): You will be asked to fill in an online diary each day about your symptoms. This can be done from your cell phone, tablet or computer and takes around 2-3 minutes each day.
- Second phone or zoom ‘visit’ (20-minutes): When you indicate via your online diary that your cold sore is healing, you will be contacted by a member of the research team to confirm your cold sore has healed, and check for any side effects of treatment. You will need to upload another photo of where your cold sore was. You will also be asked to answer a 5 to10-minute online exit survey.
- Follow up phone call (5-minutes): a researcher will ring you two weeks after the last pharmacy visit to follow up in case of any adverse events.
What are the benefits of participating?
- You may experience a reduction in the duration of your cold sore and your pain and other symptoms (such as burning or tingling).
- Once you have completed your second phone or zoom ‘visit’, you will be reimbursed for your time by way of a $60 gift voucher.
Interested in participating in this study?
For more details about this study please read the following information before deciding on whether to participate.
In order to confirm your eligibility and register your interest, please complete the online screening form below.
For more information, please contact:
Dr Mike Armour
NICM Health Research Institute, Study Chief Investigator
Human Research Ethics Committee Approval: This clinical trial has been approved by Western Sydney University Human Research Ethics Committee (Approval Number: H12776). This study is supported by NICM Health Research Institute, Western Sydney University and Sci-Chem International Pty Ltd. NICM Health Research Institute Study Chief Investigator: Dr Mike Armour