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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Keng-Fu Hsu, MD, PhD.
National Cheng-Kung University Hospital
Taiwan : Food and Drug Administration