Back to resultsSR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
Primary Purpose
Vulvar Intraepithelial Neoplasia, Genital Warts
Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Intraepithelial Neoplasia focused on measuring condyloma acuminate, ano-genital warts, genital warts, cutaneous condyloma, Vulva pre-cancerous lesions, Vulvar Intraepitheral Neoplasia, VIN, EGW
Eligibility Criteria
(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.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lesion reduction
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total clearance rate
Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.
Partial clearance rate
Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.
Full Information
NCT ID
NCT01676792
First Posted
August 29, 2012
Last Updated
April 21, 2014
Sponsor
National Cheng-Kung University Hospital
Collaborators
G&E Herbal Biotechnology Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT01676792
Brief Title
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
G&E Herbal Biotechnology Co., LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Intraepithelial Neoplasia, Genital Warts
Keywords
condyloma acuminate, ano-genital warts, genital warts, cutaneous condyloma, Vulva pre-cancerous lesions, Vulvar Intraepitheral Neoplasia, VIN, EGW
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lesion reduction
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SR-T100 gel with 2.3% of SM in Solanum undatum plant extract
Other Intervention Name(s)
SR-T100 gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients achieve greater than or equal to 75% lesion size reduction
Description
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
Time Frame
20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Secondary Outcome Measure Information:
Title
Total clearance rate
Description
Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.
Time Frame
20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Title
Partial clearance rate
Description
Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.
Time Frame
20 weeks (16weeks treatment period + 4 weeks follow-up period
Other Pre-specified Outcome Measures:
Title
Safety
Description
To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs & laboratory data changes.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
(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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keng-Fu Hsu, MD, PhD.
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
744
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
We'll reach out to this number within 24 hrs