Spots Global Cancer Trial Database for Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)

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Trial Identification

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

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

Study ID: NCT01796821

Conditions

Condyloma Acuminata

Genital Warts

Condylomata Acuminata

Venereal Warts

Interventions

Vehicle gel

SR-T100 gel with 1.0 % SM

SR-T100 gel with 2.3% SM

Study Description

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 Description: 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.