Clinical Trial: A Trial of a New Botanical Drug For the Treatment of External Condylomata Acuminata in Adult Subjects

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2, Open-label, Safety, Tolerability, and Efficacy Trial of a Botanical Drug At One Dose Level for the Treatment of External Condylomata Acuminata (Genital Warts) i

Brief Summary: This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.

Detailed Summary:

This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.

Subjects will enter the Screening Period once the informed consent process has been completed. Subjects with a clinical diagnosis of external condylomata acuminata and who meet all inclusion and none of the exclusion criteria will be enrolled.

Once subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive VIR007 (cream containing 10% EISO) with the first dose applied topically during Visit 1 (Day 1). Subjects will be instructed on how to apply the study medication twice daily for up to 60 days or until the Investigator determines the lesions have cleared. Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28, 42 and a Final Study Visit on Day 60. 30 days following complete resolution, as determined by the study investigator, or, on Study Day 90, subjects will receive a follow-up telephone call and be queried regarding condition status since study completion.


Sponsor: ViroXis Corporation

Current Primary Outcome: Incidence of treatment-emergent adverse events [ Time Frame: 60-days ]

Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of treatment-emergent tolerability issues [ Time Frame: 60-Days ]
    Tolerability will be assessed by the number of subjects reporting discomfort either during or immediately following the application of VIR007
  • Percentage of patients achieving complete clearance [ Time Frame: 60-days ]
    The percentage of subjects achieving complete clearance of all EGW lesions over the course of the trial
  • Time to clearance [ Time Frame: 60-days ]
    Time to clearance over the trial
  • Remission [ Time Frame: 90-days ]
    Percentage of subjects continuing in remission at the follow-up call


Original Secondary Outcome: Same as current

Information By: ViroXis Corporation

Dates:
Date Received: May 16, 2017
Date Started: June 2017
Date Completion: January 2018
Last Updated: May 17, 2017
Last Verified: May 2017