Status:
COMPLETED
Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
Lead Sponsor:
Wake Forest University
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
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 electrodesiccati...
Eligibility Criteria
Inclusion
- Are willing and able to give informed consent;
- Are at least 18 years of age;
- Are willing to comply with all study requirements, evaluations, and procedures
- 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
- Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
- 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
- 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.
- Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
- Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
- Are pregnant at the screening or treatment initiation visit.
- Have known allergies to any excipient in the study cream
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00314756
Start Date
March 1 2005
End Date
November 1 2005
Last Update
August 22 2023
Active Locations (1)
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1
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States, 27157