Last updated on October 2016

Safety and Efficacy Double Blind Vehicle Controlled Study of 15% AS101 Gel to Treat External Genital Warts


Brief description of study

The purpose of this double blind study is to determine whether topical 15% AS101 gel is effective and safe as compared to vehicle in the treatment of external genital warts in women.

Detailed Study Description

Females with external genital warts who meet the eligibility criteria will be randomly allocated in a blinded manner in 1:1 ratio to one of the 2 following study arms: (1) AS101 15% gel or (2) Vehicle. The patients will apply the study drug at home once daily (overnight) until complete clearance of external genital warts or for up to 14 weeks (98 days). During therapy all patients will return to the clinic every 2 weeks plus/minus 3 days of the treatment visit for clinical assessments of the treated area. At week 6 of treatment the investigator will evaluate the treated area for all patients. If the investigator determines that there is no change in the disease spread area or lesion number compared to Day 1, study therapy is to be discontinued prior to 14 weeks (98 days) of treatment and the patient will be considered as not cleared. Last observation carried forward (LOCF) method will be used to analyze such patients. Patients who at week 6 were evaluated by the investigator to have a change in the disease spread area or lesion number compared to Day 1, will continue treatment until complete clearance of warts or up to a maximum of 14 weeks (98 days). Patients who were evaluated during any of the treatment visits with complete clearance will stop to apply the study therapy, continue to be followed once per 4 weeks for 84 days (12 weeks) for safety and recurrence evaluation. Patients who completed treatment with partial clearance or patients who discontinued for reasons of other than complete clearance will be followed 28 days after discontinuation for disease progression and reference to other therapy if was recommended. Should significant irritation or any other skin adverse reaction occur during the treatment period, study therapy may be held for up to 7 consecutive days on up to two separate occasions. Unblinding: Patients will be revealed as to the nature of their treatment only after all patients have completed study. In case of pregnancy or related serious adverse event the nature of the treatment will be revealed to the patient prior to end of study. If the investigator determines that there is a disease progression in total lesion number or infected wart area size of the Day 1 treated area, study therapy is to be discontinued prior to 98 days of treatment.

Clinical Study Identifier: NCT01943630

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Shabtai Romano, MD

Ha'Emek Medical Center, Department of Gynecology and obstetrics
Afula, Israel
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Alon Ben-Arie, MD

Kaplan Medical Center, Department of Gynecology
Rehovot, Israel
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Inbar Ben-Shachar, MD

Ziv Medical Center, Department of Gynecology and obstetrics
Safed, Israel
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Dan Grisaru, MD PhD Prof

Tel-Aviv Sourasky Medical Center, Department of Gynecology
Tel-Aviv, Israel
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