Safety and Efficacy Study to Test Topical AS101 for External Genital Warts
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.
Wart; External Genital Organs
Drug: Topical AS101
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts|
- The number of patients with Adverse Events and their severity [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
- Number of patients with complete and partial clearance of external genital warts [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Number of warts that were completely or partially cleared [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Time to complete clearance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Recurrence rate in treatment area [ Time Frame: 3 months follow up ] [ Designated as safety issue: No ]
- Time to recurrence [ Time Frame: 3 months follow up ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Topical AS101
15% AS101 ointment applied twice a day for treatment of external genital warts.
Drug: Topical AS101
AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.
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.
|Gynecology department, Haemek MC||Recruiting|
|Contact: Shabtai Romano, MD 972-4-6494331 firstname.lastname@example.org|
|Sub-Investigator: Moshe Bustan, MD|
|Principal Investigator:||Shabtai Romano, MD||Ha'Emek Medical Center, Afula, Israel|