- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796795
Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients
September 13, 2023 updated by: G&E Herbal Biotechnology Co., LTD
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: vehicle gel
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.
|
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.
|
Active Comparator: SR-T100 gel with 1.0% of SM
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.
|
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.
|
Active Comparator: SR-T100 gel with 2.3% of SM
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total clearance rate of treated CW
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patient with at least 75% reduction in CW lesion counts
Time Frame: 16 weeks
|
16 weeks
|
|
Proportion of patient with at least 50% reduction in lesion size (volume)
Time Frame: 16 weeks
|
16 weeks
|
|
Mean of percent reduction in CW lesion counts from individual patient by visit
Time Frame: 16 weeks
|
16 weeks
|
|
Mean of percent reduction in CW lesion size from individual patient by visit
Time Frame: 16 weeks
|
16 weeks
|
|
CW recurrence rate
Time Frame: 28 weeks
|
28 weeks
|
|
Time to complete clearance
Time Frame: 16 weeks
|
16 weeks
|
|
Percent reduction for pooled lesion counts by visit
Time Frame: 16 weeks
|
16 weeks
|
|
Safety: evaluate the changes occurring from baseline (Randomization visit) to EOT visit.
Time Frame: 28 weeks
|
including PE, vital sign, lab.
test, local skin reaction, and adverse event, etc.
|
28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kou-Wha Kuo, Ph.D, G&E Herbal Biotechnology Co., LTD
- Principal Investigator: Hamm-Ming Sheu, MD, National Cheng-Kung University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2030
Primary Completion (Estimated)
April 1, 2033
Study Completion (Estimated)
August 1, 2033
Study Registration Dates
First Submitted
February 18, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (Estimated)
February 22, 2013
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GESRTCWA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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