At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓History of at least 3 separate recurrences of herpes labialis in the preceding 12 months
- ✓Experience prodromal symptoms (itching, tingling, burning) during at least half of previous cold sore episodes
- ✓History of at least half of cold sore episodes producing classical lesions (macule, papule, vesicle, crust, healed)
- ✕Active malignancy or immunodeficiency disease within the last 30 days
- ✕Chronic use of immunomodifying drugs (systemic steroids) or topical steroids on or near the face
- ✕Chronic use of anti-viral medication
- ✕Positive urine pregnancy test at screening (females of childbearing potential)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Placebo-Controlled, Randomized, Double-Blind Study of the Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Episodic Treatment of Recurrent Herpes Labialis
In Brief
A Phase 2 clinical trial evaluating Merlin and Ethanol for Recurrent Herpes Labialis. Completed, enrolled 451 participants across 6 sites.
Detailed 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 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 Details
Timeline
Interventions
glycolic acid/ethanol solution
Ethanol solution