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The VIBLOK SAfety and perFormancE Trial (SAFE)

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: NCT03080961
Recruitment Status : Completed
First Posted : March 15, 2017
Results First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Applied Clinical Services BV
UMC Utrecht
University of Rotterdam, The Netherlands
University of Washington
EB FlevoResearch BV
PreCare Trial & Recruitment B.V.
Information provided by (Responsible Party):
CLJI Worldwide

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HSV-2 Infection
Genital Herpes
Intervention Device: VIBLOK barrier cream
Enrollment 82
Recruitment Details Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.
Pre-assignment Details Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.
Arm/Group Title Treatment Group
Hide Arm/Group Description 46 subjects with a confirmed HSV-2 infection, took external genital skin swabs before and after applying minimally 0.8 pack (~4 ml) of VIBLOK per swab session.
Period Title: Overall Study
Started 46
Completed 43
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title As Treated Population
Hide Arm/Group Description Participants that applied VIBLOK at least once
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
Adults with recurrent genital herpes due to an HSV-2 infection and that applied VIBLOK at least once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
33.3  (10.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
39
  84.8%
Male
7
  15.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.3%
White
35
  76.1%
More than one race
2
   4.3%
Unknown or Not Reported
7
  15.2%
HSV-1 co-infection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
15
  32.6%
Number of recurrences past year  
Mean (Standard Deviation)
Unit of measure:  Episodes
Number Analyzed 46 participants
5.7  (2.60)
Years since diagnosis genital herpes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
5.8  (6.26)
1.Primary Outcome
Title Serious Adverse Device Effects
Hide Description Percentage SADE's in the as treated population.
Time Frame 26-32 days
Hide Outcome Measure Data
Hide Analysis Population Description
46 eligible subjects that applied VIBLOK for an average of 27.2 days.
Arm/Group Title During VIBLOK Application
Hide Arm/Group Description:
Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage SADE's
0
(0 to 7.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection During VIBLOK Application
Comments SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter SADE percentage
Estimated Value 0
Confidence Interval (2-Sided) 95%
0.0 to 7.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HSV-2 Detection Rate in AT Population
Hide Description Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.
Time Frame 26-32 days
Hide Outcome Measure Data
Hide Analysis Population Description
45 subjects that returned swabs before and after VIBLOK application.
Arm/Group Title Before VIBLOK After VIBLOK
Hide Arm/Group Description:
Days with HSV detection in the external genital area before application of VIBLOK.
Days with HSV detection in the external genital area after application of VIBLOK.
Overall Number of Participants Analyzed 45 45
Mean (95% Confidence Interval)
Unit of Measure: Mean number of swabs with shedding
2.9
(1.7 to 4.1)
2.6
(1.4 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before VIBLOK, After VIBLOK
Comments Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title HSV-2 Copy Number in AT Population
Hide Description Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.
Time Frame 26-32 days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.
Arm/Group Title Before VIBLOK After VIBLOK
Hide Arm/Group Description:
HSV amount in external genital swabs on days with asymptomatic shedding before applying VIBLOK.
HSV amount in external genital swabs on days with asymptomatic shedding after applying VIBLOK.
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: HSV copy number
100446.2
(24623.8 to 176268.7)
43691.8
(1954.4 to 85429.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before VIBLOK, After VIBLOK
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title ADE Description
Hide Description Nature and frequency of (possible) device related adverse events.
Time Frame 1-33 days
Hide Outcome Measure Data
Hide Analysis Population Description
AT Population that applied VIBLOK at least once.
Arm/Group Title During VIBLOK Application
Hide Arm/Group Description:
Subjects that applied VIBLOK at least once.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Count of participants per ADE type
Toxic reaction 0
Possible allergic reaction 2
Itching/tingling/burning sensation 19
Infection 0
Time Frame Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Adverse Event Reporting Description Definitions are applied conform ISO 14155; 2011.
 
Arm/Group Title During VIBLOK Application
Hide Arm/Group Description All AEs were recorded in subjects in all subjects applying VIBLOK at least once until 30 days after the last visit to the research clinic.
All-Cause Mortality
During VIBLOK Application
Affected / at Risk (%)
Total   0/46 (0.00%)    
Hide Serious Adverse Events
During VIBLOK Application
Affected / at Risk (%) # Events
Total   0/46 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
During VIBLOK Application
Affected / at Risk (%) # Events
Total   39/46 (84.78%)    
General disorders   
Other, undefined   4/46 (8.70%)  4
Infections and infestations   
Not-device related infection   11/46 (23.91%)  16
Injury, poisoning and procedural complications   
Toxic reaction   0/46 (0.00%)  0
Respiratory, thoracic and mediastinal disorders   
Possible not-device related allergic reaction   5/46 (10.87%)  5
Skin and subcutaneous tissue disorders   
Possible device related allergic reaction   2/46 (4.35%)  2
Itching/tingling/burning sensation   19/46 (41.30%)  21
HSV recurrence   19/46 (41.30%)  29
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ty Cross, President & CEO
Organization: CLJI WORLDWIDE
Phone: 305-397-8880
EMail: tycross@cljiworldwide.com
Layout table for additonal information
Responsible Party: CLJI Worldwide
ClinicalTrials.gov Identifier: NCT03080961    
Other Study ID Numbers: 2015-01
First Submitted: March 9, 2017
First Posted: March 15, 2017
Results First Submitted: February 12, 2019
Results First Posted: February 13, 2020
Last Update Posted: February 13, 2020