Trial · NCT03192306

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

NCT03192306, Phase 2, Completed, Topical Remedy; results first posted 2018-08-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores. Trials, record NCT03192306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03192306

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores
NCT number: NCT03192306
Status: Completed
Phases: Phase 2
Enrollment: 451 participants, actual
Lead sponsor: Topical Remedy
Conditions: Recurrent Herpes Labialis
Interventions: Merlin, Ethanol
First posted: 2017-06-20
Last updated: 2018-09-12
Results first posted: 2018-08-16

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinician Assessed Duration of the Classical Herpetic Lesion	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	Clinician Assessed Duration of the Herpetic Episode	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)
Secondary	Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	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
Secondary	Clinician Assessed Prevention of Progression to Classical Lesion	14 days maximum	Proportion of subjects in each treatment group who do not display classical lesions
Secondary	Clinician Assessed Lesion Size	14 days maximum	Maximum lesion area for ulcerative lesions during Stages 3-5
Secondary	Clinician Assessed Duration of the Herpetic Lesion Hard Scab	From start of Stage 5 to loss of hard crust - maximum of 14 days	Duration of the hard crust (Stage 5)
Secondary	Subject Assessed Duration of Pain	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinician Assessed Duration of the Classical Herpetic Lesion	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.	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.	hours	MEAN
SECONDARY	Clinician Assessed Duration of the Herpetic Episode	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	Subjects who developed a cold sore lesion and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.	hours	MEAN
SECONDARY	Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	From the beginning of treatment to onset of Stage 7 - maximum of 14 days	Subjects who developed a cold sore and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.	hours	MEAN
SECONDARY	Clinician Assessed Prevention of Progression to Classical Lesion	14 days maximum	Subjects who developed a cold sore lesion and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinician Assessed Lesion Size	14 days maximum	Subjects who developed a classical herpetic lesion during the course of the trial.	square mm	MEAN
SECONDARY	Clinician Assessed Duration of the Herpetic Lesion Hard Scab	From start of Stage 5 to loss of hard crust - maximum of 14 days	Only those subjects who developed a cold sore with a hard scab (Stage 5) were analyzed for this endpoint.	hours	MEAN
SECONDARY	Subject Assessed Duration of Pain	From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days	Subjects with cold sore lesions pain assessment. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Clinician Assessed Duration of the Classical Herpetic Lesion	Merlin	162.7	Standard Deviation 68.4	hours
Clinician Assessed Duration of the Classical Herpetic Lesion	Ethanol	163.6	Standard Deviation 74.9	hours
Clinician Assessed Duration of the Herpetic Episode	Merlin	151.1	Standard Deviation 70.9	hours
Clinician Assessed Duration of the Herpetic Episode	Ethanol	158.6	Standard Deviation 74.5	hours
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	Merlin	223.4	Standard Deviation 83.2	hours
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	Ethanol	222.0	Standard Deviation 86.4	hours
Clinician Assessed Prevention of Progression to Classical Lesion	Merlin	12		Participants
Clinician Assessed Prevention of Progression to Classical Lesion	Ethanol	6		Participants
Clinician Assessed Lesion Size	Merlin	46.8	Standard Deviation 50.2	square mm
Clinician Assessed Lesion Size	Ethanol	36.2	Standard Deviation 43.7	square mm

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Merlin	227
Overall Study	STARTED	Ethanol	224
Overall Study	Modified Intent to Treat (MITT)	Merlin	76
Overall Study	Modified Intent to Treat (MITT)	Ethanol	80
Overall Study	COMPLETED	Merlin	75
Overall Study	COMPLETED	Ethanol	79
Overall Study	NOT COMPLETED	Merlin	152
Overall Study	NOT COMPLETED	Ethanol	145

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diahrrhoea	Gastrointestinal disorders	Merlin	0	76	0
other	Diahrrhoea	Gastrointestinal disorders	Ethanol	1	80	1
other	Herpes Zoster	Infections and infestations	Merlin	1	76	1
other	Herpes Zoster	Infections and infestations	Ethanol	0	80	0
other	Pneumonia	Infections and infestations	Merlin	1	76	1
other	Pneumonia	Infections and infestations	Ethanol	0	80	0
other	Sialoadenitis	Infections and infestations	Merlin	0	76	0
other	Sialoadenitis	Infections and infestations	Ethanol	1	80	1
other	Sinusitis	Infections and infestations	Merlin	1	76	1
other	Sinusitis	Infections and infestations	Ethanol	1	80	1

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Merlin	0	76
Total, all-cause mortality	Ethanol	0	80
Total, other adverse events	Merlin	10	76
Total, other adverse events	Ethanol	4	80
Total, serious adverse events	Merlin	0	76
Total, serious adverse events	Ethanol	0	80

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Merlin vs Ethanol: Clinician Assessed Prevention of Progression to Classical Lesion	Trial comparisons
Merlin vs Ethanol: deaths from any cause	Trial comparisons
Merlin vs Ethanol: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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