NCT03080961

The VIBLOK SAfety and perFormancE Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: CLJI Worldwide · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	VIBLOK barrier cream	VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-11-13
• Completion: 2017-11-13
• First posted: 2017-03-15
• Last updated: 2020-02-13
• Results posted: 2020-02-13

Locations

3 sites across 1 country: Netherlands