Trial Outcomes & Findings for Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores (NCT NCT01985321)

NCT ID: NCT01985321

Last Updated: 2015-07-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 469 participants
• Primary outcome timeframe: Days 1-14
• Results posted on: 2015-07-16

Participant Flow

Subjects were recruited from the start of the study in November of 2013 until the completion of the study in March 2014. There were 8 Investigators at 8 clinical sites.

There were no notable events or approaches for the study following enrollment, but prior to group assignment. Once subjects were found to meet the eligibility requirements at the screening/randomization visit they were randomized 1:1 into the active or placebo treatment groups.

Participant milestones

Measure	Merlin - Ethanol/Glycolic Acid Solution 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol 36 applications over a 96 hour period
Overall Study STARTED	90	83
Overall Study COMPLETED	79	78
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Measure	Merlin - Ethanol/Glycolic Acid Solution 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol 36 applications over a 96 hour period
Overall Study Protocol Violation	4	3
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	5	2
Overall Study Subject treated wrong type of sore	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Merlin - Ethanol/Glycolic Acid Solution n=89 Participants 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol n=83 Participants 36 applications over a 96 hour period	Total n=172 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=93 Participants	74 Participants n=4 Participants	147 Participants n=27 Participants
Age, Categorical >=65 years	16 Participants n=93 Participants	9 Participants n=4 Participants	25 Participants n=27 Participants
Age, Continuous	48.1 Years STANDARD_DEVIATION 15.54 • n=93 Participants	48.6 Years STANDARD_DEVIATION 14.63 • n=4 Participants	48.4 Years STANDARD_DEVIATION 19 • n=27 Participants
Sex: Female, Male Female	63 Participants n=93 Participants	55 Participants n=4 Participants	118 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	28 Participants n=4 Participants	54 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=93 Participants	78 Participants n=4 Participants	162 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants
Race (NIH/OMB) Asian	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race (NIH/OMB) Black or African American	18 participants n=93 Participants	15 participants n=4 Participants	33 participants n=27 Participants
Race (NIH/OMB) White	71 participants n=93 Participants	68 participants n=4 Participants	139 participants n=27 Participants
Race (NIH/OMB) More than one race	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Region of Enrollment United States	89 participants n=93 Participants	83 participants n=4 Participants	172 participants n=27 Participants

PRIMARY outcome

Timeframe: Days 1-14

Population: 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)

Outcome measures

Measure	Merlin - Ethanol/Glycolic Acid Solution n=84 Participants 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol n=81 Participants 36 applications over a 96 hour period
Clinician Assessed Duration of Complete Healing of the Herpetic Episode	129.6 hours Interval 38.9 to 334.2	154.6 hours Interval 22.3 to 356.2

SECONDARY outcome

Timeframe: Days 1-28

Outcome measures

Measure	Merlin - Ethanol/Glycolic Acid Solution n=89 Participants 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol n=83 Participants 36 applications over a 96 hour period
Number of Treatment Related Adverse Events	9 participants	3 participants

Adverse Events

Merlin - Ethanol/Glycolic Acid Solution

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Ethanol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Merlin - Ethanol/Glycolic Acid Solution n=90 participants at risk 36 applications over a 96 hour period ethanol/glycolic acid solution: ethanol/glycolic acid solution	Ethanol n=83 participants at risk 36 applications over a 96 hour period
Gastrointestinal disorders Dyspepsia	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Gastrointestinal disorders Coeliac Disease	0.00% 0/90 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	1.2% 1/83 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Gastrointestinal disorders Food Poisoning	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
General disorders Pyrexia	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Musculoskeletal and connective tissue disorders Back Pain	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Nervous system disorders Migraine	0.00% 0/90 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	1.2% 1/83 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Skin and subcutaneous tissue disorders Pruritis	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Skin and subcutaneous tissue disorders Rash	1.1% 1/90 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Infections and infestations Nasopharyngitis	2.2% 2/90 • Number of events 2 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	1.2% 1/83 • Number of events 1 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.
Infections and infestations Upper respiratory tract infection	2.2% 2/90 • Number of events 2 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.	0.00% 0/83 • All subjects were followed daily until their cold sore lesion reached Stage 7, reporting daily for a minimum of 3 days, with the last clinic visit at the time of complete healing or at 14 days, whichever was earlier.

Additional Information

Dr. Eric M. Morrel

Benu BioPharma, Inc.

Phone: 5082085634

Email: emorrel@benubio.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 40 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and but can extend the embargo for up to 120 day to file patents or take other measures to preserve or secure its Intellectual Property.
• Publication restrictions are in place

Restriction type: OTHER