Trial Outcomes & Findings for The VIBLOK SAfety and perFormancE Trial (NCT NCT03080961)
NCT ID: NCT03080961
Last Updated: 2020-02-13
Results Overview
Percentage SADE's in the as treated population.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
26-32 days
Results posted on
2020-02-13
Participant Flow
Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.
Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.
Participant milestones
| Measure |
Treatment Group
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.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment Group
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
The VIBLOK SAfety and perFormancE Trial
Baseline characteristics by cohort
| Measure |
As Treated Population
n=46 Participants
Participants that applied VIBLOK at least once
|
|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 10.68 • n=99 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
|
HSV-1 co-infection
|
15 Participants
n=99 Participants
|
|
Number of recurrences past year
|
5.7 episodes
STANDARD_DEVIATION 2.60 • n=99 Participants
|
|
Years since diagnosis genital herpes
|
5.8 years
STANDARD_DEVIATION 6.26 • n=99 Participants
|
PRIMARY outcome
Timeframe: 26-32 daysPopulation: 46 eligible subjects that applied VIBLOK for an average of 27.2 days.
Percentage SADE's in the as treated population.
Outcome measures
| Measure |
During VIBLOK Application
n=46 Participants
Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
|
After VIBLOK
Days with HSV detection in the external genital area after application of VIBLOK.
|
|---|---|---|
|
Serious Adverse Device Effects
|
0 Percentage SADE's
Interval 0.0 to 7.7
|
—
|
SECONDARY outcome
Timeframe: 26-32 daysPopulation: 45 subjects that returned swabs before and after VIBLOK application.
Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.
Outcome measures
| Measure |
During VIBLOK Application
n=45 Participants
Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
|
After VIBLOK
n=45 Participants
Days with HSV detection in the external genital area after application of VIBLOK.
|
|---|---|---|
|
HSV-2 Detection Rate in AT Population
|
2.9 Mean number of swabs with shedding
Interval 1.7 to 4.1
|
2.6 Mean number of swabs with shedding
Interval 1.4 to 3.8
|
SECONDARY outcome
Timeframe: 26-32 daysPopulation: A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.
Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.
Outcome measures
| Measure |
During VIBLOK Application
n=25 Participants
Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
|
After VIBLOK
n=25 Participants
Days with HSV detection in the external genital area after application of VIBLOK.
|
|---|---|---|
|
HSV-2 Copy Number in AT Population
|
100446.2 HSV copy number
Interval 24623.8 to 176268.7
|
43691.8 HSV copy number
Interval 1954.4 to 85429.2
|
SECONDARY outcome
Timeframe: 1-33 daysPopulation: AT Population that applied VIBLOK at least once.
Nature and frequency of (possible) device related adverse events.
Outcome measures
| Measure |
During VIBLOK Application
n=46 Participants
Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
|
After VIBLOK
Days with HSV detection in the external genital area after application of VIBLOK.
|
|---|---|---|
|
ADE Description
Toxic reaction
|
0 Count of participants per ADE type
|
—
|
|
ADE Description
Possible allergic reaction
|
2 Count of participants per ADE type
|
—
|
|
ADE Description
Itching/tingling/burning sensation
|
19 Count of participants per ADE type
|
—
|
|
ADE Description
Infection
|
0 Count of participants per ADE type
|
—
|
Adverse Events
During VIBLOK Application
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
During VIBLOK Application
n=46 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Toxic reaction
|
0.00%
0/46 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
Skin and subcutaneous tissue disorders
Possible device related allergic reaction
|
4.3%
2/46 • Number of events 2 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
Skin and subcutaneous tissue disorders
Itching/tingling/burning sensation
|
41.3%
19/46 • Number of events 21 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
Skin and subcutaneous tissue disorders
HSV recurrence
|
41.3%
19/46 • Number of events 29 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
Infections and infestations
Not-device related infection
|
23.9%
11/46 • Number of events 16 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Possible not-device related allergic reaction
|
10.9%
5/46 • Number of events 5 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
|
General disorders
Other, undefined
|
8.7%
4/46 • Number of events 4 • Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Definitions are applied conform ISO 14155; 2011.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place