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The VIBLOK SAfety and perFormancE Trial

NCT03080961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2020-02-13

Study results available
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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.

Conditions

  • HSV-2 Infection
  • Genital Herpes

Interventions

DEVICE

VIBLOK barrier cream

VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.

Sponsors & Collaborators

  • Applied Clinical Services BV

    collaborator UNKNOWN

  • UMC Utrecht

    collaborator OTHER

  • University of Rotterdam, The Netherlands

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • EB FlevoResearch BV

    collaborator UNKNOWN

  • PreCare Trial & Recruitment B.V.

    collaborator UNKNOWN

  • CLJI Worldwide

    lead INDUSTRY

Principal Investigators

  • Vivienne vd Walle, MD · PreCare Trial & Recruitment B.V.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2017-11-13
Completion
2017-11-13

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03080961 on ClinicalTrials.gov