NCT01555112

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: BioMAS Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Wart; External Genital Organs
• Condyloma Acuminata

Interventions

Type	Name	Description
DRUG	Topical AS101	AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-03-15
• Last updated: 2013-08-15

Locations

1 site across 1 country: Israel