Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores

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.

Conditions

• Recurrent Herpes Labialis

Interventions

DRUG

Merlin

glycolic acid/ethanol solution

DRUG

Ethanol

Ethanol solution

Sponsors & Collaborators

• Benu BioPharma, LLC

  collaborator INDUSTRY

• Accelovance

  collaborator INDUSTRY

• Optimal Research

  collaborator UNKNOWN

• Topical Remedy

  lead INDUSTRY

Principal Investigators

• Stephen A Bart, Sr., M.D. · Optimal Research Rockville MD

• Murray A Kimmel, DO · Optimal Research Melbourne FL

• Daniel H Brune, MD · Optimal Research Peoria IL

• Stephen Daniels, DO · Optimal Research Austin TX

• Randle T Middleton, MD · Optimal Research Huntsville AL

• Patrick Yassini, MD · Optimal Research San Diego CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-05

Primary Completion

2017-12-11

Completion

2018-04-02

FDA Drug

Yes

Countries

• United States

Study Locations