Trial Outcomes & Findings for Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores (NCT NCT03192306)

NCT ID: NCT03192306

Last Updated: 2018-09-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

451 participants

Primary outcome timeframe

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.

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Merlin glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol Ethanol: Ethanol solution
Overall Study STARTED	227	224
Overall Study Modified Intent to Treat (MITT)	76	80
Overall Study COMPLETED	75	79
Overall Study NOT COMPLETED	152	145

Reasons for withdrawal

Reasons for withdrawal
Measure	Merlin glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol Ethanol: Ethanol solution
Overall Study Did not treat cold sore during study	149	143
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	1

Baseline Characteristics

Only subjects who developed a cold sore and treated during the course of the study were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Merlin n=227 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=224 Participants Ethanol: Ethanol solution	Total n=451 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	0 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	0 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Age, Categorical Between 18 and 65 years	73 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	77 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	150 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Age, Categorical >=65 years	3 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	3 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	6 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Age, Continuous	41.4 Years STANDARD_DEVIATION 11.84 • n=76 Participants • Only those subjects who developed a cold sore and treated were analyzed.	42.7 Years STANDARD_DEVIATION 12.8 • n=80 Participants • Only those subjects who developed a cold sore and treated were analyzed.	42.1 Years STANDARD_DEVIATION 12.32 • n=156 Participants • Only those subjects who developed a cold sore and treated were analyzed.
Sex: Female, Male Female	56 Participants n=76 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables	62 Participants n=80 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables	118 Participants n=156 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables
Sex: Female, Male Male	20 Participants n=76 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables	18 Participants n=80 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables	38 Participants n=156 Participants • Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	1 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	1 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) Asian	1 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	1 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	2 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	0 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	0 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) Black or African American	5 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	5 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	10 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) White	68 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	66 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	134 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) More than one race	2 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	3 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	5 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=76 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	4 Participants n=80 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.	4 Participants n=156 Participants • Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Region of Enrollment United States	76 participants n=76 Participants • Only subjects who developed a cold sore lesion and treated were analyzed.	80 participants n=80 Participants • Only subjects who developed a cold sore lesion and treated were analyzed.	156 participants n=156 Participants • Only subjects who developed a cold sore lesion and treated were analyzed.

PRIMARY outcome

Timeframe: 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.

Population: 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.

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

Outcome measures

Outcome measures
Measure	Merlin n=64 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=74 Participants Ethanol: Ethanol solution
Clinician Assessed Duration of the Classical Herpetic Lesion	162.7 hours Standard Deviation 68.4	163.6 hours Standard Deviation 74.9

SECONDARY outcome

Timeframe: 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

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Merlin n=75 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 Participants Ethanol: Ethanol solution
Clinician Assessed Duration of the Herpetic Episode	151.1 hours Standard Deviation 70.9	158.6 hours Standard Deviation 74.5

SECONDARY outcome

Timeframe: From the beginning of treatment to onset of Stage 7 - maximum of 14 days

Population: 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.

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

Outcome measures

Outcome measures
Measure	Merlin n=75 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 Participants Ethanol: Ethanol solution
Clinician Assessed Duration Until Complete Healing of the Herpetic Episode	223.4 hours Standard Deviation 83.2	222.0 hours Standard Deviation 86.4

SECONDARY outcome

Timeframe: 14 days maximum

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

Outcome measures

Outcome measures
Measure	Merlin n=75 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 Participants Ethanol: Ethanol solution
Clinician Assessed Prevention of Progression to Classical Lesion	12 Participants	6 Participants

SECONDARY outcome

Timeframe: 14 days maximum

Population: Subjects who developed a classical herpetic lesion during the course of the trial.

Maximum lesion area for ulcerative lesions during Stages 3-5

Outcome measures

Outcome measures
Measure	Merlin n=64 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=74 Participants Ethanol: Ethanol solution
Clinician Assessed Lesion Size	46.8 square mm Standard Deviation 50.2	36.2 square mm Standard Deviation 43.7

SECONDARY outcome

Timeframe: From start of Stage 5 to loss of hard crust - maximum of 14 days

Population: Only those subjects who developed a cold sore with a hard scab (Stage 5) were analyzed for this endpoint.

Duration of the hard crust (Stage 5)

Outcome measures

Outcome measures
Measure	Merlin n=74 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 Participants Ethanol: Ethanol solution
Clinician Assessed Duration of the Herpetic Lesion Hard Scab	66.6 hours Standard Deviation 56.8	65.9 hours Standard Deviation 62.3

SECONDARY outcome

Timeframe: From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days

Population: 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.

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

Outcome measures

Outcome measures
Measure	Merlin n=75 Participants glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 Participants Ethanol: Ethanol solution
Subject Assessed Duration of Pain First Treatment · No Pain	31 Participants	35 Participants
Subject Assessed Duration of Pain First Treatment · Mild	40 Participants	37 Participants
Subject Assessed Duration of Pain First Treatment · Moderate	4 Participants	7 Participants
Subject Assessed Duration of Pain First Treatment · Severe	0 Participants	0 Participants
Subject Assessed Duration of Pain Second Treatment · No Pain	33 Participants	32 Participants
Subject Assessed Duration of Pain Second Treatment · Mild	30 Participants	40 Participants
Subject Assessed Duration of Pain Second Treatment · Moderate	12 Participants	7 Participants
Subject Assessed Duration of Pain Second Treatment · Severe	0 Participants	1 Participants
Subject Assessed Duration of Pain Third Treatment · No Pain	29 Participants	32 Participants
Subject Assessed Duration of Pain Third Treatment · Mild	28 Participants	38 Participants
Subject Assessed Duration of Pain Third Treatment · Moderate	18 Participants	7 Participants
Subject Assessed Duration of Pain Third Treatment · Severe	0 Participants	3 Participants
Subject Assessed Duration of Pain Fourth Treatment · No Pain	31 Participants	35 Participants
Subject Assessed Duration of Pain Fourth Treatment · Mild	30 Participants	35 Participants
Subject Assessed Duration of Pain Fourth Treatment · Moderate	11 Participants	6 Participants
Subject Assessed Duration of Pain Fourth Treatment · Severe	1 Participants	2 Participants
Subject Assessed Duration of Pain Fifth Treatment · No Pain	33 Participants	34 Participants
Subject Assessed Duration of Pain Fifth Treatment · Mild	30 Participants	30 Participants
Subject Assessed Duration of Pain Fifth Treatment · Moderate	9 Participants	9 Participants
Subject Assessed Duration of Pain Fifth Treatment · Severe	1 Participants	1 Participants
Subject Assessed Duration of Pain Sixth Treatment · No Pain	38 Participants	33 Participants
Subject Assessed Duration of Pain Sixth Treatment · Mild	23 Participants	28 Participants
Subject Assessed Duration of Pain Sixth Treatment · Moderate	9 Participants	9 Participants
Subject Assessed Duration of Pain Sixth Treatment · Severe	2 Participants	0 Participants
Subject Assessed Duration of Pain Seventh Treatment · No Pain	38 Participants	31 Participants
Subject Assessed Duration of Pain Seventh Treatment · Mild	16 Participants	29 Participants
Subject Assessed Duration of Pain Seventh Treatment · Moderate	10 Participants	5 Participants
Subject Assessed Duration of Pain Seventh Treatment · Severe	1 Participants	0 Participants
Subject Assessed Duration of Pain Eighth Treatment · No Pain	40 Participants	30 Participants
Subject Assessed Duration of Pain Eighth Treatment · Mild	10 Participants	24 Participants
Subject Assessed Duration of Pain Eighth Treatment · Moderate	7 Participants	5 Participants
Subject Assessed Duration of Pain Eighth Treatment · Severe	2 Participants	0 Participants
Subject Assessed Duration of Pain Ninth Treatment · No Pain	38 Participants	31 Participants
Subject Assessed Duration of Pain Ninth Treatment · Mild	10 Participants	19 Participants
Subject Assessed Duration of Pain Ninth Treatment · Moderate	5 Participants	5 Participants
Subject Assessed Duration of Pain Ninth Treatment · Severe	2 Participants	0 Participants
Subject Assessed Duration of Pain Tenth Treatment · No Pain	32 Participants	26 Participants
Subject Assessed Duration of Pain Tenth Treatment · Mild	11 Participants	22 Participants
Subject Assessed Duration of Pain Tenth Treatment · Moderate	5 Participants	3 Participants
Subject Assessed Duration of Pain Tenth Treatment · Severe	3 Participants	0 Participants
Subject Assessed Duration of Pain Eleventh Treatment · No Pain	32 Participants	31 Participants
Subject Assessed Duration of Pain Eleventh Treatment · Mild	9 Participants	16 Participants
Subject Assessed Duration of Pain Eleventh Treatment · Moderate	4 Participants	5 Participants
Subject Assessed Duration of Pain Eleventh Treatment · Severe	2 Participants	0 Participants
Subject Assessed Duration of Pain Twelfth Treatment · No Pain	33 Participants	32 Participants
Subject Assessed Duration of Pain Twelfth Treatment · Mild	9 Participants	15 Participants
Subject Assessed Duration of Pain Twelfth Treatment · Moderate	2 Participants	4 Participants
Subject Assessed Duration of Pain Twelfth Treatment · Severe	1 Participants	0 Participants
Subject Assessed Duration of Pain Max Severity Post Treatment · No Pain	45 Participants	47 Participants
Subject Assessed Duration of Pain Max Severity Post Treatment · Mild	14 Participants	20 Participants
Subject Assessed Duration of Pain Max Severity Post Treatment · Moderate	9 Participants	8 Participants
Subject Assessed Duration of Pain Max Severity Post Treatment · Severe	2 Participants	3 Participants

Adverse Events

Merlin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ethanol

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Eric Morrel, VP Clinical Research

Benu BioPharma, Inc.

Phone: 5082085634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any manuscript, abstract, or other publication or presentation of results or information arising in connection with the study must be prepared in conjunction with Topical Remedy, LLC.
Publication restrictions are in place

Restriction type: OTHER

Measure	Merlin n=76 participants at risk glycolic acid and ethanol mixture Merlin: glycolic acid/ethanol solution	Ethanol n=80 participants at risk Ethanol: Ethanol solution
Gastrointestinal disorders Diahrrhoea	0.00% 0/76 • 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.	1.2% 1/80 • Number of events 1 • 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.
Infections and infestations Herpes Zoster	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Infections and infestations Pneumonia	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Infections and infestations Sialoadenitis	0.00% 0/76 • 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.	1.2% 1/80 • Number of events 1 • 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.
Infections and infestations Sinusitis	1.3% 1/76 • Number of events 1 • 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.	1.2% 1/80 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Infections and infestations Viral Upper Respiratory Tract Infection	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Injury, poisoning and procedural complications Laceration	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Injury, poisoning and procedural complications Muscle Strain	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/76 • 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.	1.2% 1/80 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Back Pain	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.
Nervous system disorders Headache	1.3% 1/76 • Number of events 1 • 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.	1.2% 1/80 • Number of events 1 • 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.
Nervous system disorders Syncope	0.00% 0/76 • 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.	1.2% 1/80 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/76 • 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.	1.2% 1/80 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Seborrhoeic	1.3% 1/76 • Number of events 1 • 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.	0.00% 0/80 • 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.