Condyloma AcuminataPhase 2NCT01796821
Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)
A Phase 2 study testing SR-T100 gel with 1.0 % SM and SR-T100 gel with 2.3% SM in people with Condyloma Acuminata and Genital Warts, run by G&E Herbal Biotechnology Co., LTD at 3 sites in Taiwan.
Trial summary
To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Condyloma Acuminata, Genital Warts, Condylomata Acuminata
- What is being tested?
- SR-T100 gel with 1.0 % SM and SR-T100 gel with 2.3% SM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 3 sitesTaiwan
- Study dates
- Aug 2014to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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:
- Physical modalities, such as laser ablation, electrocautery or cryotherapy, for genital warts treatment on treated area within 4 weeks prior to randomization visit.
- Topical administered medication for genital warts treatment, such as polyphenon E, podophyllotoxin, imiquimod, or 5-fluorouracil (5-FU), within 12 weeks prior to randomization.
- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City
National Cheng Kung University Hospital
Tainan
About this study
Official title: A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)
To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area.
Read the 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.
- Being tested
- Vehicle gel, SR-T100 gel with 1.0 % SM, SR-T100 gel with 2.3% SM
- Keywords
- Condyloma acuminata, Genital warts, Condylomata acuminata, Venereal warts
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: SR-T100 gel with 2.3% SM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clearance rate of baseline lesion(s)
Measured: 16 weeks
Secondary outcomes (7)
Total clearance rate of all lesion(s)
Measured: 16 weeks
Period duration of achieving total clearance of baseline lesion(s) and new lesion(s)
Measured: 16 weeks
Partial clearance rate
Measured: 16 weeks
New lesion(s) occurrence rate
Measured: 16 weeks
Recurrence rate in the 12-week follow-up time
Measured: 28 weeks
Recurrence time period
Measured: 28 weeks
Safety: evaluate the changes occurring from baseline to EOT visit
including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startAug 2014
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condyloma AcuminataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kou-Wha Kuo, PhD, Study director, G&E Herbal Biotechnology Co., LTDCheng-Yang Chou, M.D., Principal investigator, National Cheng Kung University, Tainan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796821
- Sponsor's protocol ID
- GESRTGWA
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2013
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)
- ClinicalTrials.gov ID
- NCT01796821
- Acronym / sponsor ID
- GESRTGWA
- Keywords
- Condyloma acuminata, Genital warts, Condylomata acuminata, Venereal warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle gel | Placebo comparator | Drug: Vehicle gelvehicle 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. |
| SR-T100 gel with 1.0 % SM | Active comparator | Drug: SR-T100 gel with 1.0 % SMSR-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. |
| SR-T100 gel with 2.3% SM | Active comparator | Drug: SR-T100 gel with 2.3% SMSR-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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vehicle gelClinical 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 | Vehicle gel |
| SR-T100 gel with 1.0 % SMClinical 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 |
| SR-T100 gel with 2.3% SMClinical 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 |
Primary outcome
Total clearance rate of baseline lesion(s)
Time frame: 16 weeks
7 secondary outcomes
Total clearance rate of all lesion(s)
Time frame: 16 weeks
Period duration of achieving total clearance of baseline lesion(s) and new lesion(s)
Time frame: 16 weeks
Partial clearance rate
Time frame: 16 weeks
New lesion(s) occurrence rate
Time frame: 16 weeks
Recurrence rate in the 12-week follow-up time
Time frame: 28 weeks
Recurrence time period
Time frame: 28 weeks
Safety: evaluate the changes occurring from baseline to EOT visit
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kou-Wha Kuo, PhD study director
G&E Herbal Biotechnology Co., LTD
Cheng-Yang Chou, M.D. principal investigator
National Cheng Kung University, Tainan, Taiwan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR-T100 gel with 1.0 % SM and SR-T100 gel with 2.3% SM in people with Condyloma Acuminata and Genital Warts, run by G&E Herbal Biotechnology Co., LTD at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total clearance rate of baseline lesion(s) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.