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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

Brief Summary: 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 Summary:

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
Sponsor: BioMAS Ltd

Current Primary Outcome: Change in number of warts and infected area size (absolute and percent) as compared to Day 1. [ Time Frame: within 14 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • In complete responders assessment of time to complete clearance of warts. [ Time Frame: within 14 weeks of treatment ]
  • In complete responders assessment of recurrence rate and time to recurrence. [ Time Frame: Within 3 months of follow up post treatment ]
  • Collection of patient's satisfaction data from treatment etc. [ Time Frame: within 14 weeks of treatment ]
  • Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports. [ Time Frame: within 14 weeks of treatment ]


Original Secondary Outcome:

  • 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 ]
  • In complete responders assessment of time to complete clearance of warts. [ Time Frame: within 14 weeks of treatment ]
  • In complete responders assessment of recurrence rate and time to recurrence. [ Time Frame: Within 3 months of follow up post treatment ]
  • Collection of patient's satisfaction data from treatment etc. [ Time Frame: within 14 weeks ]
  • Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports. [ Time Frame: within 14 weeks of treatment ]


Information By: BioMAS Ltd

Dates:
Date Received: September 9, 2013
Date Started: January 2015
Date Completion: May 2017
Last Updated: October 31, 2016
Last Verified: October 2016