SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
|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.
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|