Clinical Trial: Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)

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

Official Title: A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)

Brief Summary: To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area.

Detailed Summary: A double-blind, randomized,vehicle-controlled, parallel-group, and dose-ranging study to evaluate the efficacy and safety of SR-T100 gel in patients with EGW(s). The primary efficacy endpoint will be defined as the proportion of patients whose baseline EGW(s) on the treated area achieve total clearance. The efficacy of SR-T100 gel in prevention of new EGW(s) occurrence will be evaluated. Distinct to existing medications for EGWs, SR-T100 gel possesses characteristics of high safety and low LSR causality. SR-T100 gel will be administered on EGW lesion(s) for clearance and on the surrounding clinical normal skin for prevention of new EGW(s) occurrence.
Sponsor: G&E Herbal Biotechnology Co., LTD

Current Primary Outcome: Total clearance rate of baseline lesion(s) [ Time Frame: 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total clearance rate of all lesion(s) [ Time Frame: 16 weeks ]
  • Period duration of achieving total clearance of baseline lesion(s) and new lesion(s) [ Time Frame: 16 weeks ]
  • Partial clearance rate [ Time Frame: 16 weeks ]
  • New lesion(s) occurrence rate [ Time Frame: 16 weeks ]
  • Recurrence rate in the 12-week follow-up time [ Time Frame: 28 weeks ]
  • Recurrence time period [ Time Frame: 28 weeks ]
  • Safety: evaluate the changes occurring from baseline to EOT visit [ Time Frame: 28 weeks ]
    including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.


Original Secondary Outcome: Same as current

Information By: G&E Herbal Biotechnology Co., LTD

Dates:
Date Received: February 18, 2013
Date Started: August 2014
Date Completion: November 2017
Last Updated: February 17, 2016
Last Verified: February 2016