Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00314756
First received: April 12, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted

April 12, 2006
April 12, 2006
March 2005
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histologic clearance of basal cell carcinoma
Same as current
No Changes Posted
Not Provided
Not Provided
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Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage

To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Basal Cell Carcinoma
Drug: imiquimod
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2005
Not Provided

Inclusion Criteria:

  1. Are willing and able to give informed consent;
  2. Are at least 18 years of age;
  3. Are willing to comply with all study requirements, evaluations, and procedures
  4. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:

    • a primary lesion (not recurrent, not previously treated or biopsied)
    • non-infected
    • size between 0.25 and 1.5 cm2
    • located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
    • clinically consistent with nodular BCC
    • histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
    • suitable for treatment with surgical excision
    • easily identifiable and treatable by subject or reliable subject representative
  5. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
  6. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.

Exclusion Criteria:

  1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
  2. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
  3. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
  4. Are pregnant at the screening or treatment initiation visit.
  5. Have known allergies to any excipient in the study cream
  6. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00314756
BG04-484
Not Provided
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Wake Forest School of Medicine
Not Provided
Principal Investigator: Phillip M Williford, MD Wake Forest University Medical Center
Wake Forest School of Medicine
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP