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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

Tracking Information
First Submitted Date  ICMJE March 9, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE March 27, 2017
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Serious adverse device effects [ Time Frame: 26-32 days ]
Number of SADE's in 48 subjects after minimally 26 days of VIBLOK application.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03080961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The VIBLOK SAfety and perFormancE Trial
Official Title  ICMJE The VIBLOK SAfety and perFormancE Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • HSV-2 Infection
  • Genital Herpes
Intervention  ICMJE Device: VIBLOK barrier cream
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
Study Arms  ICMJE 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.
Intervention: Device: VIBLOK barrier cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2018)
82
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
48
Actual Study Completion Date  ICMJE November 13, 2017
Actual Primary Completion Date November 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080961
Other Study ID Numbers  ICMJE 2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CLJI Worldwide
Study Sponsor  ICMJE CLJI Worldwide
Collaborators  ICMJE
  • Applied Clinical Services BV
  • UMC Utrecht
  • University of Rotterdam, The Netherlands
  • University of Washington
  • EB FlevoResearch BV
  • PreCare Trial & Recruitment B.V.
Investigators  ICMJE
Principal Investigator: Vivienne vd Walle, MD PreCare Trial & Recruitment B.V.
PRS Account CLJI Worldwide
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP