Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
This study has been completed.
Information provided by:
Wake Forest University
First received: April 12, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
Basal Cell Carcinoma
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
Primary Outcome Measures:
- histologic clearance of basal cell carcinoma
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314756
|Wake Forest University Medical Center
|Winston-Salem, North Carolina, United States, 27157 |
Wake Forest University
||Phillip M Williford, MD
||Wake Forest University Medical Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 12, 2006
||April 12, 2006
||United States: Institutional Review Board
Keywords provided by Wake Forest University:
nodular basal cell carcinoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Physiological Effects of Drugs