A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence

• 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: August 11, 2005
• First Posted Date: August 12, 2005
• Last Update Posted Date: July 16, 2010
• Study Start Date: January 2004
• Actual Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2010)

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 (submitted: August 11, 2005): Efficacy

Current Secondary Outcome Measures (submitted: July 14, 2010)

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 (submitted: August 11, 2005): Cosmetic outcome
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Basal Cell Carcinoma

Intervention

Drug: Imiquimod 5% cream

Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2010): 63
• Original Enrollment (submitted: August 11, 2005): 66
• Actual Study Completion Date: January 2006
• Actual Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Basal cell carcinoma

Exclusion Criteria:

• Psoriasis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00129519
• Other Study ID Numbers: 1491-IMIQ
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Graceway Pharmaceuticals, LLC
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Graceway Pharmaceuticals, LLC
• Verification Date: July 2010