NCT01796821

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: G&E Herbal Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Condyloma Acuminata
• Genital Warts
• Condylomata Acuminata
• Venereal Warts

Interventions

Type	Name	Description
DRUG	Vehicle gel	Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.
DRUG	SR-T100 gel with 1.0 % SM	Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.
DRUG	SR-T100 gel with 2.3% SM	Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application \<1,500 mg gel per day.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2013-02-22
• Last updated: 2020-02-05

Locations

3 sites across 1 country: Taiwan