Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449982
Status:
COMPLETED
Last Update Posted:
2007-03-21
First Post:
2007-03-20
Brief Title:
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
Sponsor:
MediGene
Organization:
MediGene
Study Overview
Official Title:
A Randomized Double-Blind Three-Arm Parallel-Group Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts
Status:
COMPLETED
Status Verified Date:
2007-03
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:
The purpose of this study is to investigate the clinical efficacy safety and tolerability of a Polyphenon E Ointment 10 and a Polyphenon E Ointment 15 in the treatment of external genitial warts in male and female patients
Detailed Description:
External genital warts are non-malignant tumors caused by infections of the human papillomavirus HPV mainly types 6 and 11 Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases with about 1 of sexually active adults in the United States suffering from this infection and at least 15 with subclinical infection None of the current treatment options with exception of interferon has been subjected to controlled prospective clinical trials although they are generally regarded as safe and effective However one of their major disadvantages is that they are painful and may cause scarring Additionally recurrence of warts can often be observed Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves
Comparison Polyphenon E Ointment 10 Polyphenon E Ointment 15 placebo
Comparison Polyphenon E Ointment 10 Polyphenon E Ointment 15 placebo
Study Oversight
Has Oversight DMC:
None
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?:
None