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

Inclusion criteria

• 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 criteria

• 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.