Safety and Efficacy Study to Test Topical AS101 for External Genital Warts

Condyloma Acuminata Clinical Trial

Official title: A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.

Clinical Trial Description

Human papillomavirus (HPV)-induced condyloma acuminata (CA), commonly known as anogenital or genital warts, is among the most common sexually transmitted diseases. There are a wide variety of available treatments of genital warts, but none are considered completely effective. It has been suggested that AS101 works by stimulating the innate and acquired arms of the immune system.

In previous proof-of-concept clinical study AS101 topical cream was tested on HPV warts and shown cure in high percentages. However the cream formulation was unstable therefore a new formulation was developed mainly for the carrier. In this study the improved AS101 ointment will be tested in female patients with external genital warts in an open study to assess its safety and efficacy. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condyloma Acuminata
• Wart; External Genital Organs
• Warts

• NCT number: NCT01555112
• Study type: Interventional
• Source: BioMAS Ltd
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Completion date: July 2013