Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
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ClinicalTrials.gov Identifier: NCT00314756
: April 14, 2006
Last Update Posted
: November 6, 2017
Wake Forest University
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
Condition or disease
Basal Cell Carcinoma
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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.
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.