Clinical trial NCT01676792: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vulvar Intraepithelial Neoplasia
Genital Warts
Keywords: condyloma acuminate
ano-genital warts
genital warts
cutaneous condyloma
Vulva pre-cancerous lesions
Vulvar Intraepitheral Neoplasia
VIN
EGW
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: G&E Herbal Biotechnology Co., LTD
First posted: 2012-08-31
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patients achieve greater than or equal to 75% lesion size reduction
timeFrame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
Secondary outcomes:
measure: Total clearance rate
timeFrame: 20 weeks (16 weeks treatment period + 4 weeks follow-up period)
measure: Partial clearance rate
timeFrame: 20 weeks (16weeks treatment period + 4 weeks follow-up period
Other outcomes:
measure: Safety
timeFrame: 16 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Keng-Fu Hsu, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: