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

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ClinicalTrials.gov Identifier: NCT00129519
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : July 16, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: Imiquimod 5% cream Phase 3

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Basal cell carcinoma

Exclusion Criteria:

  • Psoriasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00129519     History of Changes
Other Study ID Numbers: 1491-IMIQ
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by Graceway Pharmaceuticals, LLC:
BCC curettage

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