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

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ClinicalTrials.gov Identifier: NCT00314756
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: imiquimod Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
Study Start Date : March 2005
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. histologic clearance of basal cell carcinoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT00314756

United States, North Carolina
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Phillip M Williford, MD Wake Forest University Medical Center

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00314756     History of Changes
Other Study ID Numbers: BG04-484
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: March 2005

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
imiquimod cream
nodular basal cell carcinoma

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