NCT00129519

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Graceway Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Imiquimod 5% cream	Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-08-12
• Last updated: 2010-07-16

Locations

3 sites across 1 country: United States