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

NCT ID: NCT01796821

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-10-31

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.

Conditions

Condyloma Acuminata; Genital Warts; Condylomata Acuminata; Venereal Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vehicle gel

vehicle gel is used as a control group. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: DRUG

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.

SR-T100 gel with 1.0 % SM

SR-T100 contains 1.0% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

Group Type: ACTIVE_COMPARATOR

SR-T100 gel with 1.0 % SM

Intervention Type: DRUG

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.

SR-T100 gel with 2.3% SM

SR-T100 contains 2.3% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

Group Type: ACTIVE_COMPARATOR

SR-T100 gel with 2.3% SM

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

11. Patients must agree to use effective boundary barrier for birth control and re-infection of EGW

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.

11. Patients with human immunodeficiency virus (HIV), venereal disease research laboratory (VDRL), or treponema pallidum particle agglutination assay (TPHA) positive result.

12. Female patients have high-grade pathology in Papanicolaou smear tests based on Bethesda system.

13. Female patients are pregnant or lactating.

14. Patients have history of allergy or sensitivity to Solanum undatum plant extract, SM, or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.

15. Patients with prohibited pre-medication or procedures shown below:

1. Physical modalities, such as laser ablation, electrocautery or cryotherapy, for genital warts treatment on treated area within 4 weeks prior to randomization visit.

2. Topical administered medication for genital warts treatment, such as polyphenon E, podophyllotoxin, imiquimod, or 5-fluorouracil (5-FU), within 12 weeks prior to randomization.

3. Medications of cytotoxic, immunomodulator (inhaled and topical steroid not on ano-genital areas are not prohibited), systematic antiviral agent in 4 weeks prior to randomization visit.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G&E Herbal Biotechnology Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kou-Wha Kuo, PhD

Role: STUDY_DIRECTOR

G&E Herbal Biotechnology Co., LTD

Cheng-Yang Chou, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University, Tainan, Taiwan

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

GESRTGWA

Identifier Type: -

Identifier Source: org_study_id