Trial record 1 of 13 for:    Open Studies | "Condylomata Acuminata"
Previous Study | Return to List | Next Study

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

This study is not yet open for participant recruitment.
Verified February 2014 by G&E Herbal Biotechnology Co., LTD
Sponsor:
Information provided by (Responsible Party):
G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier:
NCT01796821
First received: February 18, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Condyloma Acuminata
Genital Warts
Condylomata Acuminata
Venereal Warts
Drug: Vehicle gel
Drug: SR-T100 gel with 1.0 % SM
Drug: SR-T100 gel with 2.3% SM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)

Resource links provided by NLM:


Further study details as provided by G&E Herbal Biotechnology Co., LTD:

Primary Outcome Measures:
  • Total clearance rate of baseline lesion(s) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total clearance rate of all lesion(s) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Period duration of achieving total clearance of baseline lesion(s) and new lesion(s) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Partial clearance rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • New lesion(s) occurrence rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Recurrence rate in the 12-week follow-up time [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Recurrence time period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Safety: evaluate the changes occurring from baseline to EOT visit [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.


Estimated Enrollment: 130
Study Start Date: May 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle gel 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.

Active Comparator: SR-T100 gel with 1.0 % SM 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.

Active Comparator: SR-T100 gel with 2.3% SM 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.


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796821

Contacts
Contact: Kou-Wha Kuo, Ph.D. +886-6-505-2976 ext 201 kwkuo@geherbs.com.tw

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan
Contact: Chun-Nung Huang, MD. Ph.D.    886-7-3121101 ext 6694    cnhuang.uro@gmail.com   
Principal Investigator: Chun-Nung Huang, MD. PhD.         
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan
Contact: Keng-Fu Hsu, MD. Ph.D.    886-6-2353535 ext 5263    d5580@mail.ncku.edu.tw   
Principal Investigator: Keng-Fu Hsu, MD. PhD.         
Sponsors and Collaborators
G&E Herbal Biotechnology Co., LTD
Investigators
Study Director: Kou-Wha Kuo, PhD G&E Herbal Biotechnology Co., LTD
Principal Investigator: Cheng-Yang Chou, M.D. National Cheng Kung University, Tainan, Taiwan
  More Information

No publications provided

Responsible Party: G&E Herbal Biotechnology Co., LTD
ClinicalTrials.gov Identifier: NCT01796821     History of Changes
Other Study ID Numbers: GESRTGWA
Study First Received: February 18, 2013
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by G&E Herbal Biotechnology Co., LTD:
Condyloma acuminata
Genital warts
Condylomata acuminata
Venereal warts

Additional relevant MeSH terms:
Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014