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Budget issue.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle gel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total clearance rate of treated CW | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient with at least 75% reduction in CW lesion counts | 16 weeks | |
| Proportion of patient with at least 50% reduction in lesion size (volume) | 16 weeks | |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kou-Wha Kuo, Ph.D | G&E Herbal Biotechnology Co., LTD | Study Director |
| Hamm-Ming Sheu, MD | National Cheng-Kung University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| SR-T100 gel with 1.0% of SM | Drug | 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 SM | Drug | 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. |
|
| Mean of percent reduction in CW lesion counts from individual patient by visit |
| 16 weeks |
| Mean of percent reduction in CW lesion size from individual patient by visit | 16 weeks |
| CW recurrence rate | 28 weeks |
| Time to complete clearance | 16 weeks |
| Percent reduction for pooled lesion counts by visit | 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. | 28 weeks |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |