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Trial record 28 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT03192306
Recruitment Status : Completed
First Posted : June 20, 2017
Results First Posted : August 16, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Benu BioPharma, LLC
Accelovance
Optimal Research
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 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.


Condition or disease Intervention/treatment Phase
Recurrent Herpes Labialis Drug: Merlin Drug: Ethanol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Active Comparator: Merlin
glycolic acid and ethanol mixture
Drug: Merlin
glycolic acid/ethanol solution

Placebo Comparator: Ethanol Drug: Ethanol
Ethanol solution




Primary Outcome Measures :
  1. Clinician Assessed Duration of the Classical Herpetic Lesion [ Time Frame: 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. ]
    The time in hours from beginning of treatment to onset of Stage 6 (residual swelling) or Stage 7 (complete healing) if Stage 6 never observed


Secondary Outcome Measures :
  1. Clinician Assessed Duration of the Herpetic Episode [ Time Frame: 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 ]
    For classical lesions: the time in hours 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)

  2. Clinician Assessed Duration Until Complete Healing of the Herpetic Episode [ Time Frame: From the beginning of treatment to onset of Stage 7 - maximum of 14 days ]
    The time, in hours, from the beginning of treatment to onset of Stage 7

  3. Clinician Assessed Prevention of Progression to Classical Lesion [ Time Frame: 14 days maximum ]
    Proportion of subjects in each treatment group who do not display classical lesions

  4. Clinician Assessed Lesion Size [ Time Frame: 14 days maximum ]
    Maximum lesion area for ulcerative lesions during Stages 3-5

  5. Clinician Assessed Duration of the Herpetic Lesion Hard Scab [ Time Frame: From start of Stage 5 to loss of hard crust - maximum of 14 days ]
    Duration of the hard crust (Stage 5)

  6. Subject Assessed Duration of Pain [ Time Frame: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days ]
    Time of first occurrence of at least mild pain to consistent scoring of no pain



Information from the National Library of Medicine

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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): NCT03192306


Locations
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United States, Alabama
Optimal Research
Huntsville, Alabama, United States, 35802
United States, California
Optimal Research
San Diego, California, United States, 92108
United States, Florida
Optimal Research
Melbourne, Florida, United States, 32934
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Texas
Optimal Research
Austin, Texas, United States, 78705
Sponsors and Collaborators
Topical Remedy
Benu BioPharma, LLC
Accelovance
Optimal Research
Investigators
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Principal Investigator: Stephen A Bart, Sr., M.D. Optimal Research Rockville MD
Principal Investigator: Murray A Kimmel, DO Optimal Research Melbourne FL
Principal Investigator: Daniel H Brune, MD Optimal Research Peoria IL
Principal Investigator: Stephen Daniels, DO Optimal Research Austin TX
Principal Investigator: Randle T Middleton, MD Optimal Research Huntsville AL
Principal Investigator: Patrick Yassini, MD Optimal Research San Diego CA
  Study Documents (Full-Text)

Documents provided by Topical Remedy:
Study Protocol  [PDF] April 18, 2017
Statistical Analysis Plan  [PDF] August 23, 2017


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Responsible Party: Topical Remedy
ClinicalTrials.gov Identifier: NCT03192306     History of Changes
Other Study ID Numbers: TR-H-212
First Posted: June 20, 2017    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: September 12, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Topical Remedy:
Herpes Labialis
Cold Sore
Additional relevant MeSH terms:
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DNA Virus Infections
Virus Diseases
Ethanol
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Glycolic acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents