Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT01676792
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2012-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 100CT221 | OTHER | National Research Program for Biopharmaceuticals, NRPB | View |