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

NCT ID: NCT00129519

Last Updated: 2010-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-01-31

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).

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imiquimod cream

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

Group Type: ACTIVE_COMPARATOR

Imiquimod 5% cream

Intervention Type: DRUG

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

Interventions

Imiquimod 5% cream

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Basal cell carcinoma

Exclusion Criteria

• Psoriasis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Locations

Grass Valley, California, United States

Loma Linda, California, United States

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18277458 (View on PubMed)

Other Identifiers

1491-IMIQ

Identifier Type: -

Identifier Source: org_study_id