Infections

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Symptoms and General Pathology

Warts

Condylomata Acuminata

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

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.

SR-T100 gel with 2.3% of SM in Solanum undatum plant extract

Keng-Fu Hsu, MD, PhD.

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).

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.

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

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)

To evaluate safety profile of SR-T100 gel by adverse events, serious adverse events, PEs, vital signs \& laboratory data changes.

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

Proportions of patient with treated VIN(s) or EGW(s) completely eradicate.

Proportions of patient with treated VIN(s) or EGW(s) size reduction is greater than 75% in volume from baseline.

G&E Herbal Biotechnology Co., LTD

National Cheng-Kung University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma	NCT01676792	Vulvar Intraepi... Genital Warts	SR-T100 gel wit...	20 Years -	National Cheng-Kung University Hospital
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma	NCT01676792	Vulvar Intraepi... Genital Warts	SR-T100 gel wit...	20 Years -	National Cheng-Kung University Hospital

Spots Global Cancer Trial Database for vulvar intraepitheral neoplasia