A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00129519 |
Recruitment Status :
Completed
First Posted : August 12, 2005
Last Update Posted : July 16, 2010
|
Sponsor:
Graceway Pharmaceuticals, LLC
Information provided by:
Graceway Pharmaceuticals, LLC
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | August 11, 2005 | ||
First Posted Date ICMJE | August 12, 2005 | ||
Last Update Posted Date | July 16, 2010 | ||
Study Start Date ICMJE | January 2004 | ||
Actual Primary Completion Date | January 2006 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of subjects with recurrence [ Time Frame: 1 year posttreatment ] Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment
|
||
Original Primary Outcome Measures ICMJE |
Efficacy | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Cosmetic outcome of the target lesion [ Time Frame: 1 year posttreatment ] The cosmetic outcome of the target lesion at 1 year posttreatment was the secondary efficacy measurement. The investigator judged cosmetic outcome by using a visual analog scale (VAS) to assess the parameters of hypo- and hyperpigmentation,roughness, scarring, and overall skin health and appearance.
|
||
Original Secondary Outcome Measures ICMJE |
Cosmetic outcome | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence | ||
Official Title ICMJE | 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 | ||
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 ED/C 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 (5x/week) 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 recurrence/persistence (R/P). | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Basal Cell Carcinoma | ||
Intervention ICMJE | Drug: Imiquimod 5% cream
Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
|
||
Study Arms ICMJE | Active Comparator: Imiquimod cream
Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
Intervention: Drug: Imiquimod 5% cream
|
||
Publications * | Rigel DS, Torres AM, Ely H. Imiquimod 5% cream following curettage without electrodesiccation for basal cell carcinoma: preliminary report. J Drugs Dermatol. 2008 Jan;7(1 Suppl 1):s15-6. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
63 | ||
Original Enrollment ICMJE |
66 | ||
Actual Study Completion Date ICMJE | January 2006 | ||
Actual Primary Completion Date | January 2006 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00129519 | ||
Other Study ID Numbers ICMJE | 1491-IMIQ | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Graceway Pharmaceuticals, LLC | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Graceway Pharmaceuticals, LLC | ||
Verification Date | July 2010 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |