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Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT01796821•G&E Herbal Biotechnology Co., LTD

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female; aged ≥ 20 years old.
•2. Patients who accept to enter the study by signing written informed consent.
•3. Each patient has 1 to 10 clinically diagnosed EGW(s). If patient has only 1 genital wart, the diameter of the genital wart must be no less than 5 mm.
•4. Female patients have lesion(s) on labia majora, labia minora, clitoris and/or groin.
•5. Male patients have lesion(s) on glans, shaft and/or foreskin.
•6. Each patient has at least 1 histologically proved EGW.
•7. Patients agree to apply the study medication on "clinical diagnosed lesion(s)" with occlusive dressing(s) once daily for at least 20 hours per day and "clinical normal skin on the treated area" thrice daily without occlusive dressing.
•8. Patients allow diagrammed mapping and photography on genital warts. And patients agree to be used of these data as part of the study data package.
•9. Patients in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG)).
•10. Female patients with child-bearing potential must take reliable contraception method(s) during the participation of the study.
+1 more criteria

Exclusion Criteria

•1. Patients with peri-anal warts.
•2. Male patients with warts on scrotum or perineum.
•3. Patients with other genital infections.
•4. Patients with internal genital warts (such as urethral, intra-vaginal, cervical, rectal, or intra-anal genital warts).
•5. Patients with active systemic infections.
•6. Patients with other genital diseases that may confound evaluation and treatment for genital warts.
•7. Patients with immuno-compromised medical condition.
•8. Patients have received investigational drug prior to 30 days of randomization visit.
•9. Patients with cancer or cancer history within 5 years of the randomization visit.
•10. Patients have on-going human papilloma virus (HPV) infection other than genital area.
+8 more criteria

Locations (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Key Dates

Start Date

August 1, 2014

Primary Completion Date

September 1, 2018

Completion Date

October 1, 2018

Last Updated

February 5, 2020

Enrollment

138

ACTUAL participants

Conditions

Condyloma AcuminataGenital WartsCondylomata AcuminataVenereal Warts

Interventions

Vehicle gel

DRUG

SR-T100 gel with 1.0 % SM

DRUG

SR-T100 gel with 2.3% SM

DRUG

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

NCT02520986

Condylomata Acuminata

View study

COMPLETEDPHASE3

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

NCT00092534

Cervical CancerGenital Warts

View study

COMPLETED

Long Term Follow-up of HPV Vaccine in HIV (CTN 236)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Carbon Dioxide Laser vs. Electrocoagulation for the Therapy of Condyloma

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

Long Term Follow-up of HPV Vaccine in HIV (CTN 236)

Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment

Efficacy and Safety of Platelet-rich Plasma, Metformin and Cryotherapy in Treatment of Non-genital Warts

Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure