The VIBLOK SAfety and perFormancE Trial (SAFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03080961|
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|HSV-2 Infection Genital Herpes||Device: VIBLOK barrier cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|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.|
|Official Title:||The VIBLOK SAfety and perFormancE Trial|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||November 13, 2017|
|Actual Study Completion Date :||November 13, 2017|
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.
Device: VIBLOK barrier cream
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
- Serious adverse device effects [ Time Frame: 26-32 days ]Number of SADE's in 48 subjects after minimally 26 days of VIBLOK application.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080961
|Almere, Flevoland, Netherlands, 1311 RL|
|Beek, Limburg, Netherlands, 6191 JW|
|Utrecht, Netherlands, 3511 NH|
|Principal Investigator:||Vivienne vd Walle, MD||PreCare Trial & Recruitment B.V.|