Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189293
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2005-09-12
Brief Title:
Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
Sponsor:
MEDA Pharma GmbH Co KG
Organization:
Viatris Inc
Study Overview
Official Title:
Multicenter Randomised Double-blind Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5 Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
Status:
COMPLETED
Status Verified Date:
2008-09
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 compare the recurrence rate following total clearance of external genital warts EGWs when clearance has been obtained by imiquimod 3 applications per week for 4 weeks followed by ablative therapy laser or electrocautery therapy with that from just ablative therapy treatment alone
Detailed Description:
To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod 3 applications per week for 4 weeks followed by ablative therapy versus vehicle 3 applications per week for 4 weeks followed by ablative therapy A recurrence is defined as the investoigator-assessed occurrence of lesions within the baseline area cleared by the treatment imiquimodvehicle then ablative therapy either the initial ablative therápy session A0 or if required for complete clearance of baseline lesions a second ablative therapy session A2
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-004654-19 | EUDRACT_NUMBER | None | None |