Safety and Efficacy Double Blind Vehicle Controlled Study of 15% AS101 Gel to Treat External Genital Warts
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter, Randomized, Double Blind, Vehicle Controlled Study Evaluating the Efficacy and Tolerability of AS101 15% Gel for External Genital Warts.|
- Change in number of warts and infected area size (absolute and percent) as compared to Day 1. [ Time Frame: within 14 weeks of treatment ] [ Designated as safety issue: No ]
- Assessment of safety of AS101 15% gel as expressed by the occurence of local topical reactions such as erythema and edema and systemic reactions to the treatment [ Time Frame: within 14 weeks of treatment and 3 months of follow up ] [ Designated as safety issue: Yes ]
- In complete responders assessment of time to complete clearance of warts. [ Time Frame: within 14 weeks of treatment ] [ Designated as safety issue: No ]
- In complete responders assessment of recurrence rate and time to recurrence. [ Time Frame: Within 3 months of follow up post treatment ] [ Designated as safety issue: No ]
- Collection of patient's satisfaction data from treatment etc. [ Time Frame: within 14 weeks of treatment ] [ Designated as safety issue: No ]
- Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports. [ Time Frame: within 14 weeks of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: AS101
Topical 15% AS101 gel, once a day (overnight)
Drug: 15% AS101 gel
Administration of Topical 15% AS101 once a day (overnight)
Placebo Comparator: Vehicle
Vehicle, Once a day topical application (Overnight)
Administration of Vehicle once a day (overnight)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943630
|Contact: BioMas Ltdemail@example.com|
|Gynecology department, Haemek MC||Recruiting|
|Contact: Shabtai Romano, MD 972-4-6494331 firstname.lastname@example.org|
|Sub-Investigator: Moshe Bustan, MD|
|Ha'Emek Medical Center, Department of Gynecology and obstetrics||Recruiting|
|Afula, Israel, 1834111|
|Contact: S Romano, MD +972-4-6494331 email@example.com|
|Principal Investigator: S Romano, MD|
|Sub-Investigator: M Bustan, MD|
|Principal Investigator:||Shabtai Romano, MD||Ha'Emek Medical center, Department of Gynecology & obstetrics|