Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129519
Status:
COMPLETED
Last Update Posted:
2010-07-16
First Post:
2005-08-11
Brief Title:
A Study to Evaluate the Effectiveness of Imiquimod 5 Cream for Basal Cell Carcinoma Recurrence
Sponsor:
Graceway Pharmaceuticals LLC
Organization:
Graceway Pharmaceuticals LLC
Study Overview
Official Title:
Open-label Study to Evaluate the Use of Imiquimod 5 Cream for Reducing Postsurgical Recurrence or Persistence of Basal Cell Carcinoma Following Excision by Curettage
Status:
COMPLETED
Status Verified Date:
2010-07
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 primary objective of this study is to assess whether basal cell carcinoma BCC lesions surgically treated with curettage followed by imiquimod 5 cream as postsurgical adjuvant therapy will have an improved cure rate over the EDC historical norm of approximately 70 at 1-year posttreatment follow-up A secondary objective is to assess cosmetic outcome
Detailed Description:
This was an open-label phase IIIb multicenter single arm historical-controlled study Biopsy-confirmed BCC lesions 1 per subject were excised by curettage with no electrodessication Approximately 1 week later treatment with imiquimod 5 cream was initiated Imiquimod was applied to the target BCC once daily 5 times per week 5xweek for up to 6 weeks Rest periods were allowed as needed Subjects reported to the study center at treatment weeks 1 2 and 6 and posttreatment at weeks 12 26 and 52 At treatment week 6 and all posttreatment visits the investigator clinically assessed the target site for tumor clearance and cosmetic outcome A template made at initiation and created from clear plastic overlay aided in locating the target tumor site If the investigator identified a lesion that had occurred or recurred at the target site the subject was discontinued from the study and counted as a recurrencepersistence RP
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