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
Sponsor study identifier
interventional
12
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 11, 2012
Actual (reported)March 15, 2012
Actual (reported)July 2013
Actual (reported)July 2013
Actual (reported)The number of patients with Adverse Events and their severity
up to 16 weeks
Number of patients with complete and partial clearance of external genital warts
16 weeks
Number of warts that were completely or partially cleared
16 weeks
Time to complete clearance
16 weeks
Recurrence rate in treatment area
3 months follow up
Time to recurrence
3 months follow up
15% AS101 ointment applied twice a day for treatment of external genital warts.
AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gynecology department, Haemek MC
Afula, Israel
Shabtai Romano, MD
Ha'Emek Medical Center, Afula, Israel
12 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2012
First Posted
March 15, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
August 15, 2013
Record last verified: 2013-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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