Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204555
Status:
COMPLETED
Last Update Posted:
2011-09-01
First Post:
2005-09-13
Brief Title:
Safety and Efficacy Study of Imiquimod 5 Cream Applied 3x Per Week for 8 or 12 Weeks in Low Risk Nodular Basal Cell Carcinoma
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
A Randomized Open Label Study to Evaluate the Safety and Efficacy if Imiquimod 5 Cream Applied 3 Times Per Week for 8 or 12 Weeks in the Treatment of Low Risk Nodular Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs Three phase II dose response studies in subjects with nodular BCC nBCC showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing Furthermore a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks On the other hand local skin reactions increased with the doses applied per week So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety
Detailed Description:
Basal cell carcinoma BCC is a malignant skin cancer that is believed to develop from the basal layer of the epidermis Ultraviolet UV radiation is the primary cause of BCC It induces local and systemic immuno-suppression p53 mutations pyrimidine covalent dimers in desoxyribonucleic acid DNA and bcl-2 overexpression All of these UV-induced changes are believed to be critical in the pathogenesis of BCC
Topical application of imiquimod induces local interferon-alpha IFN-alpha interleukin-12 IL-12 and tumor necrosis factor-alpha TNF-alpha with a resulting cytokine cascade that may induce andor support a cytotoxic T-lymphocyte Th1 immune response Intralesional IFN-alpha has been shown to be effective for the treatment of BCC Imiquimod may be an effective therapy for BCC
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs Three phase II dose response studies in subjects with nodular BCC nBCC showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing Furthermore a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks On the other hand local skin reactions increased with the doses applied per week So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety
The current safety and efficacy study of imiquimod 5 cream in the treatment of nodular basal cell carcinoma nBCC will use a composite endpoint including both a clinical visual assessment of the target tumor site and a histological evaluation of an excisional surgery taken from the target tumor site for primary assessment of complete tumor clearance 8 weeks post treatment
Topical application of imiquimod induces local interferon-alpha IFN-alpha interleukin-12 IL-12 and tumor necrosis factor-alpha TNF-alpha with a resulting cytokine cascade that may induce andor support a cytotoxic T-lymphocyte Th1 immune response Intralesional IFN-alpha has been shown to be effective for the treatment of BCC Imiquimod may be an effective therapy for BCC
Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs Three phase II dose response studies in subjects with nodular BCC nBCC showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing Furthermore a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks On the other hand local skin reactions increased with the doses applied per week So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety
The current safety and efficacy study of imiquimod 5 cream in the treatment of nodular basal cell carcinoma nBCC will use a composite endpoint including both a clinical visual assessment of the target tumor site and a histological evaluation of an excisional surgery taken from the target tumor site for primary assessment of complete tumor clearance 8 weeks post treatment
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