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The VIBLOK SAfety and perFormancE Trial (SAFE)

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ClinicalTrials.gov Identifier: NCT03080961
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : January 9, 2018
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

Brief Summary:

Genital herpes has a high prevalence in industrialized as well as developing countries.

Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with possible serious consequences.

Medical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. Genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin.

VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin. Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over 80%.

The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults with HSV-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.


Condition or disease Intervention/treatment Phase
HSV-2 Infection Genital Herpes Device: VIBLOK barrier cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Trial participants take extra-genital swabs before and after application of the barrier cream.
Masking: None (Open Label)
Masking Description: Vials with the sample will be coded. The assessor does not know the coding.
Primary Purpose: Prevention
Official Title: The VIBLOK SAfety and perFormancE Trial
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Arm Intervention/treatment
Experimental: Before and after VIBLOK
The degree to which HSV-2 is blocked by the VIBLOK cream is determined by comparing the amount of HSV in the external genital area before and after application of the cream. So participants are their own control.
Device: VIBLOK barrier cream
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.




Primary Outcome Measures :
  1. Serious adverse device effects [ Time Frame: 26-32 days ]
    Number of SADE's in 48 subjects after minimally 26 days of VIBLOK application.


Secondary Outcome Measures :
  1. HSV-2 detection rate [ Time Frame: 26-32 days ]
    Comparison of HSV-2 DNA detection rate on days with asymptomatic shedding prior and after applying VIBLOK

  2. HSV-2 copy number [ Time Frame: 26-32 days ]
    Comparison of HSV-2 DNA copy number on days with asymptomatic shedding prior and after applying VIBLOK

  3. Safety - Nature, frequency, duration, severity, seriousness and causality of adverse events [ Time Frame: 26-32 days ]
    Nature, frequency, duration, severity, seriousness and causality of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is male or female and at least 18 years of age
  2. HSV-2 seropositive by the UW Western blot or Alegria assay
  3. History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).
  4. General good health at the discretion of the investigator.
  5. Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
  6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
  7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
  8. Willing to keep a daily trial diary during the treatment period.
  9. Negative pregnancy test for women at screening.
  10. Willing to use contraceptives for the duration of the study.
  11. Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.
  12. Subject must be willing to give written informed consent.

Exclusion Criteria:

  1. Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes
  2. Treatment with systemic steroids or other immune-modulating agents
  3. Participation in any investigational drug or device trial within 30 days prior to screening.
  4. Pregnancy or breastfeeding, in case of women.
  5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080961


Locations
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Netherlands
EB FlevoResearch
Almere, Flevoland, Netherlands, 1311 RL
PT&R
Beek, Limburg, Netherlands, 6191 JW
EB UtrechtResearch
Utrecht, Netherlands, 3511 NH
Sponsors and Collaborators
CLJI Worldwide
Applied Clinical Services BV
UMC Utrecht
University of Rotterdam, The Netherlands
University of Washington
EB FlevoResearch BV
PreCare Trial & Recruitment B.V.
Investigators
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Principal Investigator: Vivienne vd Walle, MD PreCare Trial & Recruitment B.V.

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Responsible Party: CLJI Worldwide
ClinicalTrials.gov Identifier: NCT03080961     History of Changes
Other Study ID Numbers: 2015-01
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CLJI Worldwide:
Barrier cream
Additional relevant MeSH terms:
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Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female