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 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 the stage of their lesion and how much pain, if any, related to the cold sore, that they are feeling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
451
Optimal Research
Huntsville, Alabama, United States
Optimal Research
San Diego, California, United States
Optimal Research
Melbourne, Florida, United States
Optimal Research
Peoria, Illinois, United States
Optimal Research
Rockville, Maryland, United States
Optimal Research
Austin, Texas, United States
Clinician Assessed Duration of the Classical Herpetic Lesion
The time in hours from beginning of treatment to onset of Stage 6 (residual swelling) or Stage 7 (complete healing) if Stage 6 never observed
Time frame: From time of beginning of treatment until onset of Lesion Stage 6 or Stage 7, if Stage 6 never observed, with a maximum of 14 days.
Clinician Assessed Duration of the Herpetic Episode
For classical lesions: the time in hours from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7)
Time frame: For classical lesions: from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7) - maximum of 14 days
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode
The time, in hours, from the beginning of treatment to onset of Stage 7
Time frame: From the beginning of treatment to onset of Stage 7 - maximum of 14 days
Clinician Assessed Prevention of Progression to Classical Lesion
Proportion of subjects in each treatment group who do not display classical lesions
Time frame: 14 days maximum
Clinician Assessed Lesion Size
Maximum lesion area for ulcerative lesions during Stages 3-5
Time frame: 14 days maximum
Clinician Assessed Duration of the Herpetic Lesion Hard Scab
Duration of the hard crust (Stage 5)
Time frame: From start of Stage 5 to loss of hard crust - maximum of 14 days
Subject Assessed Duration of Pain
Time of first occurrence of at least mild pain to consistent scoring of no pain
Time frame: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days
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