Safety and Efficacy Study to Test Topical AS101 for External Genital Warts
|ClinicalTrials.gov Identifier: NCT01555112|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : August 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Wart; External Genital Organs Condyloma Acuminata||Drug: Topical AS101||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts|
|Study Start Date :||March 2012|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
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.
- The number of patients with Adverse Events and their severity [ Time Frame: up to 16 weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555112
|Gynecology department, Haemek MC|
|Principal Investigator:||Shabtai Romano, MD||Ha'Emek Medical Center, Afula, Israel|