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)
Sponsor study identifier
Secondary identifiers
OTHER · National Research Program for Biopharmaceuticals, NRPB
interventional
29
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
October 2013
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2012
Actual (reported)August 31, 2012
Actual (reported)April 2013
Actual (reported)October 2013
Actual (reported)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)
Total clearance rate
20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Partial clearance rate
20 weeks (16weeks treatment period + 4 weeks follow-up period
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Cheng Kung University Hospital
Tainan, 744, Taiwan
Keng-Fu Hsu, MD, PhD.
National Cheng-Kung University Hospital
29 participants (actual enrollment reported by the registry).
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Safety
16 weeks
Contact the study team to confirm eligibility.
Primary Completion
April 2013
Actual (reported)Study Completion
October 2013
Actual (reported)Last Updated
April 22, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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