CompletedNCT03192306Updated Sep 12, 2018Results posted

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

A Phase 2 interventional study of Merlin and Ethanol in Recurrent Herpes Labialis, sponsored by Topical Remedy. Completed at 6 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-12.

Sponsored by Topical Remedy · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 451
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Herpes Labialis with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Herpes Labialis · United States.

Enrollment: 11th of 29; 451 · median 300
Started: 2017; with 1 other
Phase 2: 10 of 30; none open now
Registered: 25th of 30; by date
Lead sponsor: 2 of 30; Topical Remedy

Among the 30 studies in Herpes Labialis with a site in United States, this one is the 11th largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 in phase 2, and was the 25th registered.

Herpes Labialis

53 studies on the registry are indexed under Herpes Labialis; 2 are open to participants now.

Browse Herpes Labialis studies →

Open to participants now

2 of the 30 studies in Herpes Labialis with a site in United States are open now. Recruiting first, the newest first:

RecruitingEarly phase 1NCT06135844
Hand Sanitizer Use for Herpes Simplex Virus-1
Leciel Bono · Sites in United States
RecruitingNCT01306084
Viral Infections in Healthy and Immunocompromised Hosts
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States

All 2 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 2 Herpes Labialis studies recruiting now, 0 (0%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Watch this landscape Download CSV Narrow it in search →With an account: a weekly mail of what changed among 30 studies in Herpes Labialis with a site in United States, or all of them as a file.

Study 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.

Conditions studied

Recurrent Herpes Labialis

Browse trials for

Herpes Labialis 53

Keywords

Herpes Labialis
Cold Sore

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female subject 18-75 years of age
Female subjects must be using a medically acceptable form of 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 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 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

Exclusion Criteria:

Subjects with evidence of active 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 ) 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 , 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.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 451 participants (actual)

Study arms

Active comparator
Merlin
glycolic acid and ethanol mixture
Drug: Merlin
Placebo comparator
Ethanol
Drug: Ethanol

Interventions

DrugMerlin
glycolic acid/ethanol solution
DrugEthanol
Ethanol solution

What researchers measure

Primary outcomes

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
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.

Secondary outcomes

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)
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
The time, in hours, from the beginning of treatment to onset of Stage 7
Time frame: 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
Time frame: 14 days maximum
Clinician Assessed Lesion Size
Maximum lesion area for ulcerative lesions during Stages 3-5
Time frame: 14 days maximum
Clinician Assessed Duration of the Herpetic Lesion Hard Scab
Duration of the hard crust (Stage 5)
Time frame: 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
Time frame: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days

Results

Posted Aug 16, 2018

Participant flow

Participant flow — Overall Study
Milestone	Merlin	Ethanol
Started	227	224
Modified intent to treat (mitt)	76	80
Completed	75	79
Not completed	152	145
Withdrew: Did not treat cold sore during study	149	143
Withdrew: Withdrawal by subject	1	1
Withdrew: Lost to follow-up	1	0
Withdrew: Protocol violation	1	1

Outcome measures

PrimaryClinician 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

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.
Reported as:: Mean · hours

Clinician Assessed Duration of the Classical Herpetic Lesion
hours	Merlin	Ethanol
Clinician Assessed Duration of the Classical Herpetic Lesion	162.7 ± 68.4	163.6 ± 74.9

SecondaryClinician 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)

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
Reported as:: Mean · hours

Clinician Assessed Duration of the Herpetic Episode
hours	Merlin	Ethanol
Clinician Assessed Duration of the Herpetic Episode	151.1 ± 70.9	158.6 ± 74.5

SecondaryClinician Assessed Duration Until Complete Healing of the Herpetic Episode

The time, in hours, from the beginning of treatment to onset of Stage 7

Time frame:: From the beginning of treatment to onset of Stage 7 - maximum of 14 days
Reported as:: Mean · hours

Clinician Assessed Duration Until Complete Healing of the Herpetic Episode
hours	Merlin	Ethanol
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	223.4 ± 83.2	222.0 ± 86.4

SecondaryClinician Assessed Prevention of Progression to Classical Lesion

Proportion of subjects in each treatment group who do not display classical lesions

Time frame:: 14 days maximum
Reported as:: Count of participants · Participants

Clinician Assessed Prevention of Progression to Classical Lesion
Participants	Merlin	Ethanol
Clinician Assessed Prevention of Progression to Classical Lesion	12	6

SecondaryClinician Assessed Lesion Size

Maximum lesion area for ulcerative lesions during Stages 3-5

Time frame:: 14 days maximum
Reported as:: Mean · square mm

Clinician Assessed Lesion Size
square mm	Merlin	Ethanol
Clinician Assessed Lesion Size	46.8 ± 50.2	36.2 ± 43.7

SecondaryClinician Assessed Duration of the Herpetic Lesion Hard Scab

Duration of the hard crust (Stage 5)

Time frame:: From start of Stage 5 to loss of hard crust - maximum of 14 days
Reported as:: Mean · hours

Clinician Assessed Duration of the Herpetic Lesion Hard Scab
hours	Merlin	Ethanol
Clinician Assessed Duration of the Herpetic Lesion Hard Scab	66.6 ± 56.8	65.9 ± 62.3

SecondarySubject Assessed Duration of Pain

Time of first occurrence of at least mild pain to consistent scoring of no pain

Time frame:: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days
Reported as:: Count of participants · Participants

Subject Assessed Duration of Pain
Participants	Merlin	Ethanol
First Treatment — No Pain	31	35
First Treatment — Mild	40	37
First Treatment — Moderate	4	7
First Treatment — Severe	0	0
Second Treatment — No Pain	33	32
Second Treatment — Mild	30	40
Second Treatment — Moderate	12	7
Second Treatment — Severe	0	1
Third Treatment — No Pain	29	32
Third Treatment — Mild	28	38
Third Treatment — Moderate	18	7
Third Treatment — Severe	0	3
Fourth Treatment — No Pain	31	35
Fourth Treatment — Mild	30	35
Fourth Treatment — Moderate	11	6
Fourth Treatment — Severe	1	2
Fifth Treatment — No Pain	33	34
Fifth Treatment — Mild	30	30
Fifth Treatment — Moderate	9	9
Fifth Treatment — Severe	1	1
Sixth Treatment — No Pain	38	33
Sixth Treatment — Mild	23	28
Sixth Treatment — Moderate	9	9
Sixth Treatment — Severe	2	0
Seventh Treatment — No Pain	38	31
Seventh Treatment — Mild	16	29
Seventh Treatment — Moderate	10	5
Seventh Treatment — Severe	1	0
Eighth Treatment — No Pain	40	30
Eighth Treatment — Mild	10	24
Eighth Treatment — Moderate	7	5
Eighth Treatment — Severe	2	0
Ninth Treatment — No Pain	38	31
Ninth Treatment — Mild	10	19
Ninth Treatment — Moderate	5	5
Ninth Treatment — Severe	2	0
Tenth Treatment — No Pain	32	26
Tenth Treatment — Mild	11	22
Tenth Treatment — Moderate	5	3
Tenth Treatment — Severe	3	0
Eleventh Treatment — No Pain	32	31
Eleventh Treatment — Mild	9	16
Eleventh Treatment — Moderate	4	5
Eleventh Treatment — Severe	2	0
Twelfth Treatment — No Pain	33	32
Twelfth Treatment — Mild	9	15
Twelfth Treatment — Moderate	2	4
Twelfth Treatment — Severe	1	0
Max Severity Post Treatment — No Pain	45	47
Max Severity Post Treatment — Mild	14	20
Max Severity Post Treatment — Moderate	9	8
Max Severity Post Treatment — Severe	2	3

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Merlin	0/76 (0%)	0/76 (0%)	10/76 (13.2%)
Ethanol	0/80 (0%)	0/80 (0%)	4/80 (5%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Merlin	Ethanol
Herpes ZosterInfections and infestations	1/76	0/80
PneumoniaInfections and infestations	1/76	0/80
SinusitisInfections and infestations	1/76	1/80
Upper respiratory tract infectionInfections and infestations	1/76	0/80
Viral Upper Respiratory Tract InfectionInfections and infestations	1/76	0/80
LacerationInjury, poisoning and procedural complications	1/76	0/80
Muscle StrainInjury, poisoning and procedural complications	1/76	0/80
Back PainMusculoskeletal and connective tissue disorders	1/76	0/80
HeadacheNervous system disorders	1/76	1/80
SeborrhoeicSkin and subcutaneous tissue disorders	1/76	0/80

Baseline characteristics

Baseline Participants are all those subjects enrolled and given a Treatment Kit. Only subjects who actually developed a treatable cold sore lesion were analyzed.

Age, Categorical
Age, Categorical(Participants)	Merlin	Ethanol	Total
<=18 years	0	0	0
Between 18 and 65 years	73	77	150
>=65 years	3	3	6

Age, Continuous
Age, Continuous(Years)	Merlin	Ethanol	Total
Mean	41.4 ± 11.84	42.7 ± 12.8	42.1 ± 12.32

Sex: Female, Male
Sex: Female, Male(Participants)	Merlin	Ethanol	Total
Female	56	62	118
Male	20	18	38

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Merlin	Ethanol	Total
American Indian or Alaska Native	0	1	1
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	5	10
White	68	66	134
More than one race	2	3	5
Unknown or Not Reported	0	4	4

Region of Enrollment
Region of Enrollment(participants)	Merlin	Ethanol	Total
United States	76	80	156

Study locations

6 sites

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

References and documents

Study documents

Study protocol ↗ · Apr 18, 2017
Statistical analysis plan ↗ · Aug 23, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Dec 2017, 5 months.

Results were first posted in Aug 2018, 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 13, 2017
First posted: Jun 20, 2017
StartActual: Jul 5, 2017
Primary completionActual: Dec 11, 2017
CompletionActual: Apr 2, 2018
Results first posted: Aug 16, 2018
Last update: Sep 12, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03192306
Lead sponsor: Topical Remedy
Collaborators: Benu BioPharma, LLC, Accelovance, Optimal Research
Responsible party: Sponsor
First posted: Jun 20, 2017
Start date: Jul 5, 2017
Primary completion: Dec 11, 2017
Completion: Apr 2, 2018
Results posted: Aug 16, 2018
Last update: Sep 12, 2018

Study contacts

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

Stephen Daniels, DO

principal investigator · Optimal Research Austin TX

Randle T Middleton, MD

principal investigator · Optimal Research Huntsville AL

Patrick Yassini, MD

principal investigator · Optimal Research San Diego CA

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Herpes Labialis →

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Topical Remedy

Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold SoresCompletedNCT01985321Phase 2

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