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)
20 Years
N/A
Both
Vulvar Intraepithelial Neoplasia, Genital Warts
Trial Information
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)
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.
(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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patients achieve greater than or equal to 75% lesion size reduction
Outcome 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
Outcome Time Frame:
20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Safety Issue:
No
Principal Investigator
Keng-Fu Hsu, MD, PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cheng-Kung University Hospital
Authority:
Taiwan : Food and Drug Administration
Study ID:
100CT221
NCT ID:
NCT01676792
Start Date:
April 2011
Completion Date:
October 2013
Related Keywords:
- Vulvar Intraepithelial Neoplasia
- Genital Warts
- condyloma acuminate
- ano-genital warts
- genital warts
- cutaneous condyloma
- Vulva pre-cancerous lesions
- Vulvar Intraepitheral Neoplasia
- VIN
- EGW
- Neoplasms
- Condylomata Acuminata
- Warts
- Carcinoma in Situ
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