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| ID | Type | Description | Link |
|---|---|---|---|
| 100CT221 | Other Identifier | National Research Program for Biopharmaceuticals, NRPB |
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| Name | Class |
|---|---|
| G&E Herbal Biotechnology Co., LTD | INDUSTRY |
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This pilot clinical study is to evaluate the efficacy & safety of SR-T100 gel (2.3% of SM in Solanum undatum plant extract) in patients with VIN(s) or EGW(s).
An open-label, pilot study to evaluate the efficacy & safety profiles of SR-T100 gel in treating patients with VINs or EGWs. Male & female older than 20 years old have at least one VIN or EGW with lesion size greater than 5 mm in diameter are candidates for this study. The primary endpoint is evaluated based on patients who has received 16-week treatment and presents evaluable measurement datas by the end of 20th week. The secondary endpoints will be evaluated based on all patients with measurable values for VINs or EGWs, recruited patients in this study has never had experiencs associated with prior SR-T100 treatment of any sorts during their life time before becoming a participant in this study. The study plans to recruit 20 patients with VINs or EGWs, the enrollment duration will last two years with total of 40 patients involved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesion reduction | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR-T100 gel with 2.3% of SM in Solanum undatum plant extract | Drug | Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon & before bed time. Medication should be reapply after bathing or cleaning. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients achieve greater than or equal to 75% lesion size reduction | Proportion of patients achieving greater than or equivalent to 75% lesion size reduction from baseline on the 20th week after 16 weeks of SR-T100 gel treatment | 20 weeks (16 weeks treatment period + 4 weeks follow-up period) |
| Measure | Description | Time Frame |
|---|---|---|
| Total clearance rate | Proportions of patient with treated VIN(s) or EGW(s) completely eradicate. | 20 weeks (16 weeks treatment period + 4 weeks follow-up period) |
| Partial clearance rate | Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes. | 16 weeks |
(EGW group)Inclusion Criteria:
(EGW group)Exclusion Criteria:
(VIN group)Inclusion Criteria:
(VIN group)Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keng-Fu Hsu, MD, PhD. | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 744 | Taiwan |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| 20 weeks (16weeks treatment period + 4 weeks follow-up period |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |