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

Phase 3

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Drug: Imiquimod 5% cream

• Registration Number: NCT00129519
• Lead Sponsor: Graceway Pharmaceuticals, LLC

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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Basal cell carcinoma

Exclusion Criteria

• Psoriasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of subjects with recurrence	1 year posttreatment	Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment

Secondary Outcome Measures

Name	Time	Method
Cosmetic outcome of the target lesion	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.