Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192306
Recruitment Status : Completed
First Posted : June 20, 2017
Results First Posted : August 16, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Benu BioPharma, LLC
Accelovance
Optimal Research
Information provided by (Responsible Party):
Topical Remedy

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Recurrent Herpes Labialis
Interventions Drug: Merlin
Drug: Ethanol
Enrollment 451
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Period Title: Overall Study
Started 227 224
Modified Intent to Treat (MITT) [1] 76 80
Completed 75 79
Not Completed 152 145
Reason Not Completed
Did not treat cold sore during study             149             143
Withdrawal by Subject             1             1
Lost to Follow-up             1             0
Protocol Violation             1             1
[1]
MITT represents data collected from enrolled subjects who developed a cold sore and treated.
Arm/Group Title Merlin Ethanol Total
Hide Arm/Group Description

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution Total of all reporting groups
Overall Number of Baseline Participants 227 224 451
Hide Baseline Analysis Population Description
Baseline Participants are all those subjects enrolled and given a Treatment Kit. Only subjects who actually developed a treatable cold sore lesion were analyzed.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 80 participants 156 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
  96.1%
77
  96.3%
150
  96.2%
>=65 years
3
   3.9%
3
   3.8%
6
   3.8%
[1]
Measure Analysis Population Description: Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 80 participants 156 participants
41.4  (11.84) 42.7  (12.8) 42.1  (12.32)
[1]
Measure Analysis Population Description: Only those subjects who developed a cold sore and treated were analyzed.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 80 participants 156 participants
Female
56
  73.7%
62
  77.5%
118
  75.6%
Male
20
  26.3%
18
  22.5%
38
  24.4%
[1]
Measure Analysis Population Description: Only subjects who had a cold sore and treated during the course of the study were summarized in demographics tables
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 80 participants 156 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   0.6%
Asian
1
   1.3%
1
   1.3%
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   6.6%
5
   6.3%
10
   6.4%
White
68
  89.5%
66
  82.5%
134
  85.9%
More than one race
2
   2.6%
3
   3.8%
5
   3.2%
Unknown or Not Reported
0
   0.0%
4
   5.0%
4
   2.6%
[1]
Measure Analysis Population Description: Only subjects who developed a cold sore and treated during the course of the study were analyzed.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 80 participants 156 participants
76 80 156
[1]
Measure Analysis Population Description: Only subjects who developed a cold sore lesion and treated were analyzed.
1.Primary Outcome
Title Clinician Assessed Duration of the Classical Herpetic Lesion
Hide Description 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
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 64 74
Mean (Standard Deviation)
Unit of Measure: hours
162.7  (68.4) 163.6  (74.9)
2.Secondary Outcome
Title Clinician Assessed Duration of the Herpetic Episode
Hide Description 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)
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 75 80
Mean (Standard Deviation)
Unit of Measure: hours
151.1  (70.9) 158.6  (74.5)
3.Secondary Outcome
Title Clinician Assessed Duration Until Complete Healing of the Herpetic Episode
Hide Description The time, in hours, from the beginning of treatment to onset of Stage 7
Time Frame From the beginning of treatment to onset of Stage 7 - maximum of 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 75 80
Mean (Standard Deviation)
Unit of Measure: hours
223.4  (83.2) 222.0  (86.4)
4.Secondary Outcome
Title Clinician Assessed Prevention of Progression to Classical Lesion
Hide Description Proportion of subjects in each treatment group who do not display classical lesions
Time Frame 14 days maximum
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 75 80
Measure Type: Count of Participants
Unit of Measure: Participants
12
  16.0%
6
   7.5%
5.Secondary Outcome
Title Clinician Assessed Lesion Size
Hide Description Maximum lesion area for ulcerative lesions during Stages 3-5
Time Frame 14 days maximum
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who developed a classical herpetic lesion during the course of the trial.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 64 74
Mean (Standard Deviation)
Unit of Measure: square mm
46.8  (50.2) 36.2  (43.7)
6.Secondary Outcome
Title Clinician Assessed Duration of the Herpetic Lesion Hard Scab
Hide Description Duration of the hard crust (Stage 5)
Time Frame From start of Stage 5 to loss of hard crust - maximum of 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only those subjects who developed a cold sore with a hard scab (Stage 5) were analyzed for this endpoint.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 74 80
Mean (Standard Deviation)
Unit of Measure: hours
66.6  (56.8) 65.9  (62.3)
7.Secondary Outcome
Title Subject Assessed Duration of Pain
Hide Description Time of first occurrence of at least mild pain to consistent scoring of no pain
Time Frame From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description:

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
Overall Number of Participants Analyzed 75 80
Measure Type: Count of Participants
Unit of Measure: Participants
First Treatment Number Analyzed 75 participants 79 participants
No Pain
31
  41.3%
35
  44.3%
Mild
40
  53.3%
37
  46.8%
Moderate
4
   5.3%
7
   8.9%
Severe
0
   0.0%
0
   0.0%
Second Treatment Number Analyzed 75 participants 80 participants
No Pain
33
  44.0%
32
  40.0%
Mild
30
  40.0%
40
  50.0%
Moderate
12
  16.0%
7
   8.8%
Severe
0
   0.0%
1
   1.3%
Third Treatment Number Analyzed 75 participants 80 participants
No Pain
29
  38.7%
32
  40.0%
Mild
28
  37.3%
38
  47.5%
Moderate
18
  24.0%
7
   8.8%
Severe
0
   0.0%
3
   3.8%
Fourth Treatment Number Analyzed 73 participants 78 participants
No Pain
31
  42.5%
35
  44.9%
Mild
30
  41.1%
35
  44.9%
Moderate
11
  15.1%
6
   7.7%
Severe
1
   1.4%
2
   2.6%
Fifth Treatment Number Analyzed 73 participants 74 participants
No Pain
33
  45.2%
34
  45.9%
Mild
30
  41.1%
30
  40.5%
Moderate
9
  12.3%
9
  12.2%
Severe
1
   1.4%
1
   1.4%
Sixth Treatment Number Analyzed 72 participants 70 participants
No Pain
38
  52.8%
33
  47.1%
Mild
23
  31.9%
28
  40.0%
Moderate
9
  12.5%
9
  12.9%
Severe
2
   2.8%
0
   0.0%
Seventh Treatment Number Analyzed 65 participants 65 participants
No Pain
38
  58.5%
31
  47.7%
Mild
16
  24.6%
29
  44.6%
Moderate
10
  15.4%
5
   7.7%
Severe
1
   1.5%
0
   0.0%
Eighth Treatment Number Analyzed 59 participants 59 participants
No Pain
40
  67.8%
30
  50.8%
Mild
10
  16.9%
24
  40.7%
Moderate
7
  11.9%
5
   8.5%
Severe
2
   3.4%
0
   0.0%
Ninth Treatment Number Analyzed 55 participants 55 participants
No Pain
38
  69.1%
31
  56.4%
Mild
10
  18.2%
19
  34.5%
Moderate
5
   9.1%
5
   9.1%
Severe
2
   3.6%
0
   0.0%
Tenth Treatment Number Analyzed 51 participants 51 participants
No Pain
32
  62.7%
26
  51.0%
Mild
11
  21.6%
22
  43.1%
Moderate
5
   9.8%
3
   5.9%
Severe
3
   5.9%
0
   0.0%
Eleventh Treatment Number Analyzed 47 participants 52 participants
No Pain
32
  68.1%
31
  59.6%
Mild
9
  19.1%
16
  30.8%
Moderate
4
   8.5%
5
   9.6%
Severe
2
   4.3%
0
   0.0%
Twelfth Treatment Number Analyzed 45 participants 51 participants
No Pain
33
  73.3%
32
  62.7%
Mild
9
  20.0%
15
  29.4%
Moderate
2
   4.4%
4
   7.8%
Severe
1
   2.2%
0
   0.0%
Max Severity Post Treatment Number Analyzed 70 participants 78 participants
No Pain
45
  64.3%
47
  60.3%
Mild
14
  20.0%
20
  25.6%
Moderate
9
  12.9%
8
  10.3%
Severe
2
   2.9%
3
   3.8%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Merlin Ethanol
Hide Arm/Group Description

glycolic acid and ethanol mixture

Merlin: glycolic acid/ethanol solution

Ethanol: Ethanol solution
All-Cause Mortality
Merlin Ethanol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)      0/80 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Merlin Ethanol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/80 (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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/76 (13.16%)      4/80 (5.00%)    
Gastrointestinal disorders     
Diahrrhoea * 1  0/76 (0.00%)  0 1/80 (1.25%)  1
Infections and infestations     
Herpes Zoster * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Pneumonia * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Sialoadenitis * 1  0/76 (0.00%)  0 1/80 (1.25%)  1
Sinusitis * 1  1/76 (1.32%)  1 1/80 (1.25%)  1
Upper respiratory tract infection * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Viral Upper Respiratory Tract Infection * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Injury, poisoning and procedural complications     
Laceration * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Muscle Strain * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Skin Abrasion * 1  0/76 (0.00%)  0 1/80 (1.25%)  1
Musculoskeletal and connective tissue disorders     
Back Pain * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
Nervous system disorders     
Headache * 1  1/76 (1.32%)  1 1/80 (1.25%)  1
Syncope * 1  0/76 (0.00%)  0 1/80 (1.25%)  1
Respiratory, thoracic and mediastinal disorders     
Sinus Congestion * 1  0/76 (0.00%)  0 1/80 (1.25%)  1
Skin and subcutaneous tissue disorders     
Seborrhoeic * 1  1/76 (1.32%)  1 0/80 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Morrel, VP Clinical Research
Organization: Benu BioPharma, Inc.
Phone: 5082085634
EMail: emorrel@benubio.com
Layout table for additonal information
Responsible Party: Topical Remedy
ClinicalTrials.gov Identifier: NCT03192306     History of Changes
Other Study ID Numbers: TR-H-212
First Submitted: June 13, 2017
First Posted: June 20, 2017
Results First Submitted: June 18, 2018
Results First Posted: August 16, 2018
Last Update Posted: September 12, 2018