Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110682
Status:
COMPLETED
Last Update Posted:
2008-04-24
First Post:
2005-05-12
Brief Title:
Study of Imiquimod 5 Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
Sponsor:
Derm Research 888 Inc
Organization:
Derm Research 888 Inc
Study Overview
Official Title:
A Randomized Parallel-Group Vehicle-Controlled Double-Blind Study of Topical Imiquimod 5 Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses With a Long-Term 1 Year Follow-Up
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Study Aims
To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups
Hypothesis The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses AK compared to the vehicle arm
To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups
Hypothesis The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses AK compared to the vehicle arm
Detailed Description:
Evaluation of i topical imiquimod 5 cream or ii vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy
Study Aims
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups
To assess and compare the efficacy of the 2 different treatment groups
To assess and compare the safety of the 2 different treatment groups
Study Design 6 visits over 62 weeks
Study Aims
To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups
To assess and compare the efficacy of the 2 different treatment groups
To assess and compare the safety of the 2 different treatment groups
Study Design 6 visits over 62 weeks
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