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

Genital Warts Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676792
• Other study ID #: 100CT221
• Secondary ID: 100CT221
• Status: Completed
• Phase: Phase 0
• First received: August 29, 2012
• Last updated: April 21, 2014
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug AdministrationTaiwan: National Health Research Institutes
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

(EGW group)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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Condylomata Acuminata
• Genital Warts
• Neoplasms
• Vulvar Intraepithelial Neoplasia
• Warts

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	G&E Herbal Biotechnology Co., LTD

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes.	16 weeks	Yes
Primary	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)	No
Secondary	Total clearance rate	Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.	20 weeks (16 weeks treatment period + 4 weeks follow-up period)	No
Secondary	Partial clearance rate	Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.	20 weeks (16weeks treatment period + 4 weeks follow-up period	No