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
  Purpose

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


Condition Intervention Phase
Basal Cell Carcinoma
Drug: imiquimod
Phase 4

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: Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • histologic clearance of basal cell carcinoma

Estimated Enrollment: 15
Study Start Date: March 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00314756

Locations
United States, North Carolina
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Phillip M Williford, MD Wake Forest University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314756     History of Changes
Other Study ID Numbers: BG04-484
Study First Received: April 12, 2006
Last Updated: April 12, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
imiquimod cream
nodular basal cell carcinoma
curettage

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

ClinicalTrials.gov processed this record on October 29, 2014