SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
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|ClinicalTrials.gov Identifier: NCT01676792|
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : April 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vulvar Intraepithelial Neoplasia Genital Warts||Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Efficacy & Safety of Topical SR-T100 Gel in the Treatment of Human Vulva Pre-cancerous Lesions (Vulvar Intraepithelial Neoplasia; VIN) & Cutaneous Condyloma(External Genital Warts; EGWs)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||October 2013|
|Experimental: Lesion reduction||
Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
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.
Other Name: SR-T100 gel
- Patients achieve greater than or equal to 75% lesion size reduction [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ]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
- Total clearance rate [ Time Frame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period) ]Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.
- Partial clearance rate [ Time Frame: 20 weeks (16weeks treatment period + 4 weeks follow-up period ]Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.
- Safety [ Time Frame: 16 weeks ]To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676792
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 744|
|Principal Investigator:||Keng-Fu Hsu, MD, PhD.||National Cheng-Kung University Hospital|