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

Early Phase 1

Completed

• Conditions: Vulvar Intraepithelial Neoplasia; Genital Warts
• Interventions: Drug: SR-T100 gel with 2.3% of SM in Solanum undatum plant extract

• Registration Number: NCT01676792
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Primary Completion: 2013-04
• Study Completion: 2013-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-21
• Last Update Posted: 2014-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Male & female patients older than 20 years old presents at least one pathologically confirmed with histopathology EGW with lesion size greater than 5mm in diameter.

(EGW group)

Exclusion Criteria

• Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy & lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.

(VIN group)Inclusion Criteria:

• Female patients older than 20 years old presents at least one histopathologically confirmed VIN with lesion size greater than 5mm in diameter.

(VIN group)Exclusion Criteria:

• Patients with invasive neoplasia, enlarged lymph nodes invasive squamous cell carcinoma, having treated with other investigational drugs within 30 days, pregnancy & lactating females, female with pregnancy potential without using effective boundary barrier or patients with immune-deficience.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lesion reduction	SR-T100 gel with 2.3% of SM in Solanum undatum plant extract	-

Primary Outcome Measures

Name	Time	Method
Patients achieve greater than or equal to 75% lesion size reduction	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

Secondary Outcome Measures

Name	Time	Method
Total clearance rate	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	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.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan