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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Collaborator: G&E Herbal Biotechnology Co., LTD

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.