Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
Condition: Recurrent Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: ethanol/glycolic acid solution; Placebo/Ethanol
Intervention description: ethanol/glycolic acid solution; ethanol solution
Intervention MeSH terms: Ethanol; Glycolic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 469.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: herpes labialis; cold sore

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.
    

Eligibility 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.