Common WartPhase 2NCT01796795
Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients
A Phase 2 study testing SR-T100 gel with 1.0% of SM and SR-T100 gel with 2.3% of SM in people with Common Wart, run by G&E Herbal Biotechnology Co., LTD.
Trial summary
This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant extract) in patients with CW. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Common Wart
- What is being tested?
- SR-T100 gel with 1.0% of SM and SR-T100 gel with 2.3% of SM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Sep 2030to Aug 2033
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 17 years old.
- The diagnosis of CW is based on visual inspection by an experienced dermatologist.
- Patient is selected ≤ 5 CW lesions; each of the target lesion(s) needs to be ≤ 15 mm in diameter. For patient with only 1 selected lesion, the size of target lesion needs to be measuring 2 to 15 mm in diameter.
- Patient agrees to apply the study medication on target CW lesion(s) with an occlusive dressing for at least 20 hours per day.
- Patient or the legally acceptable representative of patient under 20 years of age, is willing and able to provide written informed consent.
- Patient agrees not to use wart-removing product/modality (prescription or over-the-counter) other than the study product during the course of the study; and is willing to refrain from using cosmetics or other topical products in the treatment area for the duration of the study.
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- Any non-target CW receiving wart-removing procedures including cryotherapy and surgical therapy should be at least 5 cm apart from the target lesions.
- Patient is free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk to the patient.
- Patient is judged to be in good health based upon the results of physical examinations (PEs), medical history, and safety laboratory tests.
- Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG)).
- Patient agrees to be photographed of the CW target lesion(s) and used of such data as part of the study package.
- Female patient of childbearing potential should have a negative urine or serum pregnancy test at Screening day, and is willing to use effective contraception during the study.
Who cannot join
- The treatment area is located in any of the following areas: the eye area (including eyelids), lips, mouth cavity, nasal cavity,inner ear, soles of the feet, underneath the nails, and the anogenital area.
- Patient had participated in a clinical study within 30 days prior to the Randomization visit, or is currently participating in another clinical study.
- Patient had used any wart-removing product/modality in the treatment area within 30 days prior to the Randomization visit or received cryotherapy in the treatment area within 60 days prior to the Randomization visit.
- Patient who has immune-compromised conditions, have required or will require systemic intake of immunosuppressive or immunomodulatory medication (oral or parental corticosteroids are included) within 30 days prior to the Randomization visit or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed.
- Patient has clinically significant or unstable medical conditions (psychologically and physically) in any of the following listed situations:
- Clinically significant peripheral vascular disease based on medical history.
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- Current uncontrolled infection, current skin infections and/or skin disorder in the treatment area other than CW and/or in the area surrounding the warts that may confound or affect study assessment procedure of the study endpoints.
- Chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk (including human immunodeficiency virus, systemic lupus erythematosis, active viral hepatitis, etc.).
- Patient is pregnant, plan to become pregnant, or is breastfeeding.
- Patient has a history of allergy or sensitivity to Solanum undatum plant extract, SM, or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.
About this study
Official title: A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients.
This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant extract) in patients with CW.
- Conditions
- Common Wart
- Being tested
- Vehicle gel, SR-T100 gel with 1.0% of SM, SR-T100 gel with 2.3% of SM
- Keywords
- common wart, verruca vulgaris
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle gelDrug
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
SR-T100 gel with 1.0% of SMDrug
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
SR-T100 gel with 2.3% of SMDrug
Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
| Study group | Role | What they receive |
|---|---|---|
| vehicle gel | Placebo comparator | The vehicle gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. Receives: Drug: Vehicle gel |
| SR-T100 gel with 1.0% of SM | Active comparator | SR-T100 contains 1.0% SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. Receives: Drug: SR-T100 gel with 1.0% of SM |
| SR-T100 gel with 2.3% of SM | Active comparator | SR-T100 contains 2.3%SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. Receives: Drug: SR-T100 gel with 2.3% of SM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clearance rate of treated CW
Measured: 16 weeks
Secondary outcomes (8)
Proportion of patient with at least 75% reduction in CW lesion counts
Measured: 16 weeks
Proportion of patient with at least 50% reduction in lesion size (volume)
Measured: 16 weeks
Mean of percent reduction in CW lesion counts from individual patient by visit
Measured: 16 weeks
Mean of percent reduction in CW lesion size from individual patient by visit
Measured: 16 weeks
CW recurrence rate
Measured: 28 weeks
Time to complete clearance
Measured: 16 weeks
Percent reduction for pooled lesion counts by visit
Measured: 16 weeks
Safety: evaluate the changes occurring from baseline (Randomization visit) 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 startSep 2030 (estimated)
- Primary completionApr 2033 (estimated)
- Study completionAug 2033 (estimated)
Why it stopped: Budget issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartStudies 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G&E Herbal Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kou-Wha Kuo, Ph.D, Study director, G&E Herbal Biotechnology Co., LTDHamm-Ming Sheu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796795
- Sponsor's protocol ID
- GESRTCWA
- Status last verified
- Sep 2023
- First submitted
- 18 Feb 2013
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients.
- ClinicalTrials.gov ID
- NCT01796795
- Acronym / sponsor ID
- GESRTCWA
- Conditions
- Common Wart
- Keywords
- common wart, verruca vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Budget issue.
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- G&E Herbal Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Sep 2030 (estimated)
- Primary completion
- Apr 2033 (estimated)
- Study completion
- Aug 2033 (estimated)
- 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.
This phase II study is to evaluate the efficacy of SR-T100 gel in complete clearance of target warts at different concentrations (1.0% and 2.3% of SM in Solanum undatum plant extract) in patients with CW.
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 gelThe vehicle gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. |
| SR-T100 gel with 1.0% of SM | Active comparator | Drug: SR-T100 gel with 1.0% of SMSR-T100 contains 1.0% SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. |
| SR-T100 gel with 2.3% of SM | Active comparator | Drug: SR-T100 gel with 2.3% of SMSR-T100 contains 2.3%SM. The gel will be applied in appropriate amount evenly and gently in a thin-layer of gel by finger, not to exceed 0.2 g per administration (approximately 2 cm gel squeezed in length). Each dose of study drug is applied on the target lesion(s) and covered with an occlusive dressing for the entire day. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 17 years old.
- The diagnosis of CW is based on visual inspection by an experienced dermatologist.
- Patient is selected ≤ 5 CW lesions; each of the target lesion(s) needs to be ≤ 15 mm in diameter. For patient with only 1 selected lesion, the size of target lesion needs to be measuring 2 to 15 mm in diameter.
- Patient agrees to apply the study medication on target CW lesion(s) with an occlusive dressing for at least 20 hours per day.
- Patient or the legally acceptable representative of patient under 20 years of age, is willing and able to provide written informed consent.
Key exclusion criteria (10 listed)
- The treatment area is located in any of the following areas: the eye area (including eyelids), lips, mouth cavity, nasal cavity,inner ear, soles of the feet, underneath the nails, and the anogenital area.
- Patient had participated in a clinical study within 30 days prior to the Randomization visit, or is currently participating in another clinical study.
- Patient had used any wart-removing product/modality in the treatment area within 30 days prior to the Randomization visit or received cryotherapy in the treatment area within 60 days prior to the Randomization visit.
- Patient who has immune-compromised conditions, have required or will require systemic intake of immunosuppressive or immunomodulatory medication (oral or parental corticosteroids are included) within 30 days prior to the Randomization visit or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed.
- Patient has clinically significant or unstable medical conditions (psychologically and physically) in any of the following listed situations:
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 gelTopical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration. | Drug | vehicle gel |
| SR-T100 gel with 1.0% of SMTopical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration. | Drug | SR-T100 gel with 1.0% of SM |
| SR-T100 gel with 2.3% of SMTopical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration. | Drug | SR-T100 gel with 2.3% of SM |
Primary outcome
Total clearance rate of treated CW
Time frame: 16 weeks
8 secondary outcomes
Proportion of patient with at least 75% reduction in CW lesion counts
Time frame: 16 weeks
Proportion of patient with at least 50% reduction in lesion size (volume)
Time frame: 16 weeks
Mean of percent reduction in CW lesion counts from individual patient by visit
Time frame: 16 weeks
Mean of percent reduction in CW lesion size from individual patient by visit
Time frame: 16 weeks
CW recurrence rate
Time frame: 28 weeks
Time to complete clearance
Time frame: 16 weeks
Percent reduction for pooled lesion counts by visit
Time frame: 16 weeks
Safety: evaluate the changes occurring from baseline (Randomization visit) to EOT visit.
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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, Ph.D study director
G&E Herbal Biotechnology Co., LTD
Hamm-Ming Sheu, MD principal investigator
National Cheng-Kung University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR-T100 gel with 1.0% of SM and SR-T100 gel with 2.3% of SM in people with Common Wart, run by G&E Herbal Biotechnology Co., LTD.
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 12 inclusion and 10 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: paused, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 treated CW (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 14 Sep 2023.