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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: BioMAS Ltd

Current Primary Outcome: The number of patients with Adverse Events and their severity [ Time Frame: up to 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with complete and partial clearance of external genital warts [ Time Frame: 16 weeks ]
  • Number of warts that were completely or partially cleared [ Time Frame: 16 weeks ]
  • Time to complete clearance [ Time Frame: 16 weeks ]
  • Recurrence rate in treatment area [ Time Frame: 3 months follow up ]
  • Time to recurrence [ Time Frame: 3 months follow up ]


Original Secondary Outcome: Same as current

Information By: BioMAS Ltd

Dates:
Date Received: March 11, 2012
Date Started: March 2012
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013