Recurrent Herpes LabialisPhase 2NCT03192306

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

A Phase 2 study testing Merlin and Ethanol in people with Recurrent Herpes Labialis, run by Topical Remedy at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Recurrent Herpes Labialis
What is being tested?: Merlin and Ethanol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 451 participants
Where: 6 sitesUnited States
Study dates: 5 Jul 2017to 2 Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Optimal Research
Austin, Texas, 78705
Optimal Research
Huntsville, Alabama, 35802
Optimal Research
Melbourne, Florida, 32934
Optimal Research
Peoria, Illinois, 61614
Optimal Research
Rockville, Maryland, 20850
Optimal Research
San Diego, California, 92108

Other trials in United States

About this study

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

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
Being tested: Merlin, Ethanol
Keywords: Herpes Labialis, Cold Sore
Medical subject headings: Herpes Labialis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MerlinDrug
glycolic acid/ethanol solution
EthanolDrug
Ethanol solution

Study groups in NCT03192306
Study group	Role	What they receive
Merlin	Active comparator	glycolic acid and ethanol mixture Receives: Drug: Merlin
Ethanol	Placebo comparator	Not described Receives: Drug: Ethanol

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinician Assessed Duration of the Classical Herpetic Lesion
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
Measured: 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 (6)

Clinician Assessed Duration of the Herpetic Episode
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)
Measured: 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
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode
The time, in hours, from the beginning of treatment to onset of Stage 7
Measured: From the beginning of treatment to onset of Stage 7 - maximum of 14 days
Clinician Assessed Prevention of Progression to Classical Lesion
Proportion of subjects in each treatment group who do not display classical lesions
Measured: 14 days maximum
Clinician Assessed Lesion Size
Maximum lesion area for ulcerative lesions during Stages 3-5
Measured: 14 days maximum
Clinician Assessed Duration of the Herpetic Lesion Hard Scab
Duration of the hard crust (Stage 5)
Measured: From start of Stage 5 to loss of hard crust - maximum of 14 days
Subject Assessed Duration of Pain
Time of first occurrence of at least mild pain to consistent scoring of no pain
Measured: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 20172 Apr 2018

First posted20 Jun 2017
Study start5 Jul 2017
Primary completion11 Dec 2017
Study completion2 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Herpes LabialisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 451 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03192306
Sponsor's protocol ID: TR-H-212
Status last verified: Aug 2018
First submitted: 13 Jun 2017
Last updated: 12 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03192306
Acronym / sponsor ID: TR-H-212
Conditions: Recurrent Herpes Labialis
Keywords: Herpes Labialis, Cold Sore
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 451 participants (actual)
Lead sponsor: Topical RemedyIndustry (pharma, biotech, devices)
Collaborators: Benu BioPharma, LLC, Accelovance, Optimal Research
Study start: 5 Jul 2017 (actual)
Primary completion: 11 Dec 2017 (actual)
Study completion: 2 Apr 2018 (actual)
First posted: 20 Jun 2017 (actual)
Results: Posted 16 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Merlin	Active comparator	Drug: Merlinglycolic acid and ethanol mixture
Ethanol	Placebo comparator	Drug: Ethanol

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Merlinglycolic acid/ethanol solution	Drug	Merlin
EthanolEthanol solution	Drug	Ethanol

Primary outcome

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

6 secondary outcomes

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
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
Clinician Assessed Prevention of Progression to Classical Lesion
Time frame: 14 days maximum
Clinician Assessed Lesion Size
Time frame: 14 days maximum
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
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

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Merlin	227	75
Ethanol	224	79

Primary outcome: 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.. Mean (Standard Deviation). Unit: hours

Measure	Merlin n = 64	Ethanol n = 74
Value	162.7 (68.4)	163.6 (74.9)

Population analysed: Only those subjects who developed a classical cold sore lesion, i.e. exhibited Stages 3, 4 or 5, during the course of the trial and treated were analyzed for this endpoint.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected during the course of treatment until the herpetic lesion healed, or for 14 days from the first report of a cold sore, whichever occurred first, for all those who developed a cold sore in the study, and for two weeks after completion of treatment or for two weeks after the 14 day Treatment Phase study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Merlin	0 of 76 (0%)	10 of 76 (13.2%)	0 of 76
Ethanol	0 of 80 (0%)	4 of 80 (5%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen A Bart, Sr., M.D. principal investigator

Optimal Research Rockville MD

Murray A Kimmel, DO principal investigator

Optimal Research Melbourne FL

Daniel H Brune, MD principal investigator

Optimal Research Peoria IL

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Merlin and Ethanol in people with Recurrent Herpes Labialis, run by Topical Remedy at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.