Recurrent Herpes Labialis Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03977792 -
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
|
Phase 2 | |
| Completed |
NCT00248144 -
A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis
|
Phase 4 | |
| Active, not recruiting |
NCT05098938 -
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
|
Phase 3 | |
| Completed |
NCT01985321 -
Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
|
Phase 2 | |
| Completed |
NCT01324466 -
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
|
Phase 3 | |
| Completed |
NCT00914745 -
Place Controlled Study to Treat Recurrent Herpes Labialis.
|
Phase 2 |