Trial · NCT01985321

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

NCT01985321, Phase 2, Completed, Topical Remedy; results first posted 2015-05-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores. Trials, record NCT01985321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01985321

On this page

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 the Treatment of Cold Sores
NCT number: NCT01985321
Status: Completed
Phases: Phase 2
Enrollment: 469 participants, actual
Lead sponsor: Topical Remedy
Conditions: Recurrent Herpes Labialis
Interventions: ethanol/glycolic acid solution, Placebo/Ethanol
First posted: 2013-11-15
Last updated: 2015-07-16
Results first posted: 2015-05-28

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Clinician Assessed Duration of Complete Healing of the Herpetic Episode	Days 1-14
Secondary	Number of Treatment Related Adverse Events	Days 1-28

Source ClinicalTrials.gov

Outcomes2

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 Complete Healing of the Herpetic Episode	Days 1-14	Modified Intent to Treat Population: 2 subjects in placebo group violated protocol and could not be evaluated for Complete Healing (83-2=81). 5 subjects in active group started treatment prior to contacting site; 1 subject in active group lost to follow-up with no site visits. These 6 active subjects not used in Complete Healing analysis (90-6=84)	hours	MEDIAN
SECONDARY	Number of Treatment Related Adverse Events	Days 1-28		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Clinician Assessed Duration of Complete Healing of the Herpetic Episode	Merlin - Ethanol/Glycolic Acid Solution	129.6	Full Range 38.9 to 334.2	hours
Clinician Assessed Duration of Complete Healing of the Herpetic Episode	Ethanol	154.6	Full Range 22.3 to 356.2	hours
Number of Treatment Related Adverse Events	Merlin - Ethanol/Glycolic Acid Solution	9		participants
Number of Treatment Related Adverse Events	Ethanol	3		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Merlin - Ethanol/Glycolic Acid Solution	90
Overall Study	STARTED	Ethanol	83
Overall Study	COMPLETED	Merlin - Ethanol/Glycolic Acid Solution	79
Overall Study	COMPLETED	Ethanol	78
Overall Study	NOT COMPLETED	Merlin - Ethanol/Glycolic Acid Solution	11
Overall Study	NOT COMPLETED	Ethanol	5

Source ClinicalTrials.gov

Adverse events24

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	Dyspepsia	Gastrointestinal disorders	Merlin - Ethanol/Glycolic Acid Solution	1	90	1
other	Dyspepsia	Gastrointestinal disorders	Ethanol	0	83	0
other	Coeliac Disease	Gastrointestinal disorders	Merlin - Ethanol/Glycolic Acid Solution	0	90	0
other	Coeliac Disease	Gastrointestinal disorders	Ethanol	1	83	1
other	Food Poisoning	Gastrointestinal disorders	Merlin - Ethanol/Glycolic Acid Solution	1	90	1
other	Food Poisoning	Gastrointestinal disorders	Ethanol	0	83	0
other	Pyrexia	General disorders	Merlin - Ethanol/Glycolic Acid Solution	1	90	1
other	Pyrexia	General disorders	Ethanol	0	83	0
other	Back Pain	Musculoskeletal and connective tissue disorders	Merlin - Ethanol/Glycolic Acid Solution	1	90	1
other	Back Pain	Musculoskeletal and connective tissue disorders	Ethanol	0	83	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Merlin - Ethanol/Glycolic Acid Solution
Total, all-cause mortality	Ethanol
Total, other adverse events	Merlin - Ethanol/Glycolic Acid Solution	9	90
Total, other adverse events	Ethanol	3	83
Total, serious adverse events	Merlin - Ethanol/Glycolic Acid Solution	0	90
Total, serious adverse events	Ethanol	0	83

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 comparisons2

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

Comparison	Source
Merlin - Ethanol/Glycolic Acid Solution vs Ethanol: Number of Treatment Related Adverse Events	Trial comparisons
Merlin - Ethanol/Glycolic Acid Solution 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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01985321

GET https://conductscience.org/api/trials/v1/NCT01985321/events?page=2

API reference For AI assistants