Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,
is safe and effective in the treatment of cold sores.
Subjects who meet the requirements to participate in the study will be put randomly, and
equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a
group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor
the site will know which treatment they will be getting. Once the subject has been assigned
to a treatment group, they will be given a kit containing a bottle of the treatment and
special swabs to apply the liquid. The subject will be told to take the kit home and wait
until they think they are starting to get a cold sore.
Once a subject begins to feel something or see something that they think is the start of a
cold sore, they are to immediately call the clinic. Once the clinic confirms that the subject
is in fact starting to get a cold sore, the subject will be told to open the kit and begin
treatment. From the start of treatment, there will be twelve (12) treatments, with either
Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96 hours (4
days). Each treatment of Merlin or placebo is made up of three (3) applications given twenty
(20) minutes apart, for a total of thirty-six (36) applications. FOr each application, the
subject will use the special swab to put the Merlin or placebo solution on their cold sore.
Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until
either the cold sore is completely healed or 14 days from the start of treatment, whichever
comes first. At each clinic visit the cold sore will be observed to determine at what stage
it is at or if it has healed. The subject will also be asked how they are feeling.
Subjects will also be told to record in a diary the time of each application of Merlin or
placebo. They will also be asked to record how much pain, if any, related to the cold sore,
that they are feeling.