CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
VIBLOK barrier creamdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03080961
NCT03080961N/ACompleted

The VIBLOK SAfety and perFormancE Trial

CLJI Worldwide·interventional·Posted Mar 15, 2017·Updated Feb 13, 2020

In Brief

A clinical study evaluating VIBLOK barrier cream for HSV-2 Infection and Genital Herpes. Completed, enrolled 82 participants across 3 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 15, 2017
Enrollment StartMar 27, 2017
Primary CompletionNov 13, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

VIBLOK barrier creamdevice

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