NCT01796821

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2014

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

4.1 years

First QC Date

February 18, 2013

Last Update Submit

February 3, 2020

Conditions

Condyloma AcuminataGenital WartsCondylomata AcuminataVenereal Warts

Keywords

Condyloma acuminataGenital wartsCondylomata acuminataVenereal warts

Outcome Measures

Primary Outcomes (1)

  • Total clearance rate of baseline lesion(s)

    16 weeks

Secondary Outcomes (7)

  • Total clearance rate of all lesion(s)

    16 weeks

  • Period duration of achieving total clearance of baseline lesion(s) and new lesion(s)

    16 weeks

  • Partial clearance rate

    16 weeks

  • New lesion(s) occurrence rate

    16 weeks

  • Recurrence rate in the 12-week follow-up time

    28 weeks

  • +2 more secondary outcomes

Study Arms (3)

Vehicle gel

PLACEBO COMPARATOR

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.

Drug: Vehicle gel

SR-T100 gel with 1.0 % SM

ACTIVE COMPARATOR

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.

Drug: SR-T100 gel with 1.0 % SM

SR-T100 gel with 2.3% SM

ACTIVE COMPARATOR

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.

Drug: SR-T100 gel with 2.3% SM

Interventions

Vehicle gelDRUG

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.

Vehicle gel
SR-T100 gel with 1.0 % SMDRUG

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 gel with 2.3% SMDRUG

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female; aged ≥ 20 years old.
  • Patients who accept to enter the study by signing written informed consent.
  • 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.
  • Female patients have lesion(s) on labia majora, labia minora, clitoris and/or groin.
  • Male patients have lesion(s) on glans, shaft and/or foreskin.
  • Each patient has at least 1 histologically proved EGW.
  • 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.
  • 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.
  • Patients in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG)).
  • Female patients with child-bearing potential must take reliable contraception method(s) during the participation of the study.
  • Patients must agree to use effective boundary barrier for birth control and re-infection of EGW

You may not qualify if:

  • Patients with peri-anal warts.
  • Male patients with warts on scrotum or perineum.
  • Patients with other genital infections.
  • Patients with internal genital warts (such as urethral, intra-vaginal, cervical, rectal, or intra-anal genital warts).
  • Patients with active systemic infections.
  • Patients with other genital diseases that may confound evaluation and treatment for genital warts.
  • Patients with immuno-compromised medical condition.
  • Patients have received investigational drug prior to 30 days of randomization visit.
  • Patients with cancer or cancer history within 5 years of the randomization visit.
  • Patients have on-going human papilloma virus (HPV) infection other than genital area.
  • Patients with human immunodeficiency virus (HIV), venereal disease research laboratory (VDRL), or treponema pallidum particle agglutination assay (TPHA) positive result.
  • Female patients have high-grade pathology in Papanicolaou smear tests based on Bethesda system.
  • Female patients are pregnant or lactating.
  • Patients have history of allergy or sensitivity to Solanum undatum plant extract, SM, or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.
  • Patients with prohibited pre-medication or procedures shown below:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kou-Wha Kuo, PhD

    G&E Herbal Biotechnology Co., LTD

    STUDY DIRECTOR

  • Cheng-Yang Chou, M.D.

    National Cheng Kung University, Tainan, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 22, 2013

Study Start

August 1, 2014

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

TW(3)