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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
82
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
EB FlevoResearch
Almere Stad, Flevoland, Netherlands
PT&R
Beek, Limburg, Netherlands
EB UtrechtResearch
Utrecht, Netherlands
Serious Adverse Device Effects
Percentage SADE's in the as treated population.
Time frame: 26-32 days
HSV-2 Detection Rate in AT Population
Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.
Time frame: 26-32 days
HSV-2 Copy Number in AT Population
Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.
Time frame: 26-32 days
ADE Description
Nature and frequency of (possible) device related adverse events.
Time frame: 1-33 days
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