Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01985321|
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : May 28, 2015
Last Update Posted : July 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Herpes Labialis||Drug: ethanol/glycolic acid solution Drug: Placebo/Ethanol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||469 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Merlin - ethanol/glycolic acid solution
36 applications over a 96 hour period
Drug: ethanol/glycolic acid solution
ethanol/glycolic acid solution
Other Name: Merlin
Placebo Comparator: Placebo/Ethanol
36 applications over a 96 hour period
Other Name: Placebo
- Clinician Assessed Duration of Complete Healing of the Herpetic Episode [ Time Frame: Days 1-14 ]
- Number of Treatment Related Adverse Events [ Time Frame: Days 1-28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985321
|United States, California|
|Santa Rosa, California, United States, 95405|
|United States, Florida|
|Pinellas Park, Florida, United States, 33781|
|United States, Illinois|
|Chicago, Illinois, United States, 60654|
|United States, Minnesota|
|Edina, Minnesota, United States, 55435|
|United States, Missouri|
|St. Louis, Missouri, United States, 63141|
|United States, Ohio|
|Akron, Ohio, United States, 44311|
|Cincinnati, Ohio, United States, 45249|
|United States, Texas|
|Dallas, Texas, United States, 75231|