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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
Sponsor:
Collaborator:
Benu BioPharma, LLC
Information provided by (Responsible Party):
Topical Remedy

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 469 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
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
Drug: Placebo/Ethanol
ethanol solution
Other Name: Placebo




Primary Outcome Measures :
  1. Clinician Assessed Duration of Complete Healing of the Herpetic Episode [ Time Frame: Days 1-14 ]

Secondary Outcome Measures :
  1. Number of Treatment Related Adverse Events [ Time Frame: Days 1-28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject 18-75 years of age
  • Female subjects must be using a medically acceptable form of birth control during the study. Acceptable birth control measures include, but are not limited to: abstinence, oral contraceptive pills or patch, injectable contraception, barrier contraceptives (condom, diaphragm with spermicide), IUD, vaginal contraceptive ring, surgical (hysterectomy, tubal ligation), vasectomized partner, and natural post-menopausal inability to conceive. Menopause is defined for this protocol as starting one year after the time of the last menstrual period.
  • Subject must have a history of recurrent herpes labialis and report at least 3 separate recurrences (i.e. multiple herpetic lesions in one outbreak count as only one episode) during the preceding 12 months.
  • Subject must have a history of experiencing prodromal symptoms of cold sores (e.g. itching, tingling, or burning) during at least half of their previous cold sore episodes.
  • Subject must have a history of at least half of their cold sore episodes producing classical lesions (i.e., episodes that progressed through macule, papule, vesicle, crust, and healed).
  • Subject must provide voluntary written informed consent to participate in this study.
  • Subject is able to appear for a clinic visit within 24 hours from the time of treating cold sore and is able to return to the clinic for the full 14 day duration of the study if necessary.

Exclusion Criteria:

  • Subjects with evidence of active malignancy or immunodeficiency disease within the last 30 days. Subjects who have completed therapy and are considered unlikely to relapse or who have had surgery and do not have any evidence of disease, are eligible for the study.
  • Subject requires chronic use of immunomodifying drugs (e.g. systemic steroids) or topical steroids on or near the face; use of inhaled steroids does not exclude a subject from the study. If a subject is unlikely to get through the Treatment Phase of the protocol without requiring the use of an immunomodifying drug for a chronic condition the subject should be excluded.
  • Subject requires chronic use of anti-viral medication.
  • In females of childbearing potential, a positive urine pregnancy test at time of screening.
  • Nursing mothers.
  • Subject has abnormal skin conditions (e.g. acne, eczema, rosacea, psoriasis, albinism, or chronic vesiculobullous disorders) that occur in the area ordinarily affected by cold sores or has significant facial hair in the area of the cold sore that might affect the normal course of the cold sore or might impair accurate evaluation of the cold sore lesion.
  • Subject has had a vaccine for herpes simplex virus type 1 (typically oral herpes) or 2 (typically genital herpes).
  • Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
  • Subject requires chronic use of analgesics or non-steroidal anti-inflammatory agents (NSAIDs) except for low doses of aspirin (less than 325 mg/day) used for cardiovascular purposes. If a subject is unlikely to get through the Treatment Phase of the protocol without requiring the use of analgesia for a chronic condition, e.g. back pain, recurrent daily headaches, the subject should be excluded.

Information from the National Library of Medicine

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


Locations
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United States, California
Radiant Research
Santa Rosa, California, United States, 95405
United States, Florida
Radiant Research
Pinellas Park, Florida, United States, 33781
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60654
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
United States, Ohio
Radiant Research
Akron, Ohio, United States, 44311
Radiant Research
Cincinnati, Ohio, United States, 45249
United States, Texas
Radiant Reserach
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Topical Remedy
Benu BioPharma, LLC

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Responsible Party: Topical Remedy
ClinicalTrials.gov Identifier: NCT01985321     History of Changes
Other Study ID Numbers: TR-H-211
First Posted: November 15, 2013    Key Record Dates
Results First Posted: May 28, 2015
Last Update Posted: July 16, 2015
Last Verified: June 2015
Keywords provided by Topical Remedy:
herpes labialis
cold sore
Additional relevant MeSH terms:
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Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Ethanol
Glycolic acid
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents