Do you suffer from Cold Sores?
Cold Sores are small and unusually painful blisters on the skin of the lips or mouth caused by the Herpes Simplex virus.
To be eligible for this study, you must:
- Be 18 years of age or over
- Have a history of the clinical signs (symptoms such as itching, tingling pain etc) with 4 or more episodes in the preceding 12 months
The purpose of this project is to evaluate a single dose of acyclovir Lauriad® 50 mg muco-adhesive buccal tablet compared with inactive (placebo) treatment for cold sores in patient’s in general good health
The safety and how well it works will be evaluated by recording and assessing
the time to healing; from the beginning of the treatment, which is when you apply
the tablet to the gum, to the moment where the herpes crust falls.
The name of the investigational new drug that you may take in this study is
acyclovir Lauriad® (50mg tablet). Investigational means that the drug has not been
approved by Health Authorities including the Therapeutic Goods Administration –
Australia. The active medicine, however, is acyclovir which is commonly used
worldwide to treat cold sores. In this study the drug will be administered in a muco-
adhesive buccal tablet. This means that the tablet sticks to the gum, near the upper
canine tooth, and delivers rapidly and progressively, acyclovir in your saliva.
The investigational new drug, acyclovir Lauriad® 50mg muco-adhesive buccal
tablet has not been given to humans with active cold sores. It has been
administered to healthy volunteers and was well tolerated.
There is a 50% chance of receiving placebo (non active medication) instead of the
Investigational drug. This way the results of both arms of the Study, active drug
and inactive drug can be accurately compared
Information on the study provided herein is extracted from the consent form approved by the relevant Ethics Board– potential participants in the study should obtain the approved consent form for their review.
PLEASE SEE ALSO CLINICAL TRIALS OVERVIEW
For more information, or a copy of the Consent Form, please email us at trials@holdsworthhouse.com.au
Or call the trials team on (02) 9331 7228
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