Clinical trial NCT03192306: Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Herpes Labialis
Keywords: Herpes Labialis
Cold Sore
Lead sponsor: Topical Remedy
Sponsor class: INDUSTRY
Collaborators: name: Benu BioPharma, LLC
name: Accelovance
name: Optimal Research
First posted: 2017-06-20
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Clinician Assessed Duration of the Classical Herpetic Lesion
timeFrame: From time of beginning of treatment until onset of Lesion Stage 6 or Stage 7, if Stage 6 never observed, with a maximum of 14 days.
Secondary outcomes:
measure: Clinician Assessed Duration of the Herpetic Episode
timeFrame: For classical lesions: from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7) - maximum of 14 days
measure: Clinician Assessed Duration Until Complete Healing of the Herpetic Episode
timeFrame: From the beginning of treatment to onset of Stage 7 - maximum of 14 days
measure: Clinician Assessed Prevention of Progression to Classical Lesion
timeFrame: 14 days maximum
measure: Clinician Assessed Lesion Size
timeFrame: 14 days maximum
measure: Clinician Assessed Duration of the Herpetic Lesion Hard Scab
timeFrame: From start of Stage 5 to loss of hard crust - maximum of 14 days
measure: Subject Assessed Duration of Pain
timeFrame: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Austin
country: United States
facility: Optimal Research
state: Texas
Study officials:
affiliation: Optimal Research Rockville MD
name: Stephen A Bart, Sr., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Research Melbourne FL
name: Murray A Kimmel, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Research Peoria IL
name: Daniel H Brune, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Research Austin TX
name: Stephen Daniels, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Research Huntsville AL
name: Randle T Middleton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Optimal Research San Diego CA
name: Patrick Yassini, MD
role: PRINCIPAL_INVESTIGATOR
References: