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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00129519
First received: August 11, 2005
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: Imiquimod 5% cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Number of subjects with recurrence [ Time Frame: 1 year posttreatment ] [ Designated as safety issue: No ]
    Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment


Secondary Outcome Measures:
  • Cosmetic outcome of the target lesion [ Time Frame: 1 year posttreatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: January 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Imiquimod cream
Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
Drug: Imiquimod 5% cream
Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Basal cell carcinoma

Exclusion Criteria:

  • Psoriasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129519

Locations
United States, California
Grass Valley, California, United States, 95945
Loma Linda, California, United States, 92354
United States, New York
New York, New York, United States, 10016
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00129519     History of Changes
Other Study ID Numbers: 1491-IMIQ
Study First Received: August 11, 2005
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
BCC curettage

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Recurrence
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Pathologic Processes
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014