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Trial record 29 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT01985321
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : May 28, 2015
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Benu BioPharma, LLC
Information provided by (Responsible Party):
Topical Remedy

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Recurrent Herpes Labialis
Interventions Drug: ethanol/glycolic acid solution
Drug: Placebo/Ethanol
Enrollment 469
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Merlin - Ethanol/Glycolic Acid Solution Ethanol
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36 applications over a 96 hour period

ethanol/glycolic acid solution: ethanol/glycolic acid solution

36 applications over a 96 hour period
Period Title: Overall Study
Started 90 [1] 83 [1]
Completed 79 78
Not Completed 11 5
Reason Not Completed
Protocol Violation             4             3
Withdrawal by Subject             1             0
Lost to Follow-up             5             2
Subject treated wrong type of sore             1             0
[1]
This is Treatment Eligible Subjects only
Arm/Group Title Merlin - Ethanol/Glycolic Acid Solution Ethanol Total
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36 applications over a 96 hour period

ethanol/glycolic acid solution: ethanol/glycolic acid solution

36 applications over a 96 hour period Total of all reporting groups
Overall Number of Baseline Participants 89 83 172
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Safety population of the modified intent to treat population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 83 participants 172 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
  82.0%
74
  89.2%
147
  85.5%
>=65 years
16
  18.0%
9
  10.8%
25
  14.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 83 participants 172 participants
48.1  (15.54) 48.6  (14.63) 48.4  (19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 83 participants 172 participants
Female
63
  70.8%
55
  66.3%
118
  68.6%
Male
26
  29.2%
28
  33.7%
54
  31.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 83 participants 172 participants
Hispanic or Latino
5
   5.6%
5
   6.0%
10
   5.8%
Not Hispanic or Latino
84
  94.4%
78
  94.0%
162
  94.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 83 participants 172 participants
American Indian or Alaska Native 0 2 2
Asian 0 2 2
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 18 15 33
White 71 68 139
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 83 participants 172 participants
89 83 172
1.Primary Outcome
Title Clinician Assessed Duration of Complete Healing of the Herpetic Episode
Hide Description [Not Specified]
Time Frame Days 1-14
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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)
Arm/Group Title Merlin - Ethanol/Glycolic Acid Solution Ethanol
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36 applications over a 96 hour period

ethanol/glycolic acid solution: ethanol/glycolic acid solution

36 applications over a 96 hour period
Overall Number of Participants Analyzed 84 81
Median (Full Range)
Unit of Measure: hours
129.6
(38.9 to 334.2)
154.6
(22.3 to 356.2)
2.Secondary Outcome
Title Number of Treatment Related Adverse Events
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Time Frame Days 1-28
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Merlin - Ethanol/Glycolic Acid Solution Ethanol
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36 applications over a 96 hour period

ethanol/glycolic acid solution: ethanol/glycolic acid solution

36 applications over a 96 hour period
Overall Number of Participants Analyzed 89 83
Measure Type: Number
Unit of Measure: participants
9 3
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Merlin - Ethanol/Glycolic Acid Solution Ethanol
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36 applications over a 96 hour period

ethanol/glycolic acid solution: ethanol/glycolic acid solution

36 applications over a 96 hour period
All-Cause Mortality
Merlin - Ethanol/Glycolic Acid Solution Ethanol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Merlin - Ethanol/Glycolic Acid Solution Ethanol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/90 (0.00%)      0/83 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Merlin - Ethanol/Glycolic Acid Solution Ethanol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/90 (10.00%)      3/83 (3.61%)    
Gastrointestinal disorders     
Dyspepsia  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Coeliac Disease  1  0/90 (0.00%)  0 1/83 (1.20%)  1
Food Poisoning  1  1/90 (1.11%)  1 0/83 (0.00%)  0
General disorders     
Pyrexia  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  2/90 (2.22%)  2 1/83 (1.20%)  1
Upper respiratory tract infection  1  2/90 (2.22%)  2 0/83 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Nervous system disorders     
Migraine  1  0/90 (0.00%)  0 1/83 (1.20%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Respiratory Tract Congestion  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritis  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Rash  1  1/90 (1.11%)  1 0/83 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Dr. Eric M. Morrel
Organization: Benu BioPharma, Inc.
Phone: 5082085634
EMail: emorrel@benubio.com
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Responsible Party: Topical Remedy
ClinicalTrials.gov Identifier: NCT01985321     History of Changes
Other Study ID Numbers: TR-H-211
First Submitted: November 8, 2013
First Posted: November 15, 2013
Results First Submitted: May 11, 2015
Results First Posted: May 28, 2015
Last Update Posted: July 16, 2015