Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- Procedure: Electrodessication & Curettage
- Registration Number
- NCT00994240
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED\&C x 1 cycle or ED\&C x 3 cycles) using computer generated random numbers. One cycle of ED\&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED\&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED\&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
- Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
- Age greater than 21
- Women with childbearing potential (including those who are pregnant/lactating)
- Able to provide written informed consent
- Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
- Prior history of BCC or other skin cancer at the same location
- Lesion > 2 cm
- Patients with basal cell nevus syndrome
- Transplant patients
- Immunocompromised patients
- Recurrent BCC
- Greater than 2 BCC-S on the trunk and/or extremities
- Prisoners
- Allergy to lidocaine or epinephrine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ED&C times 3 cycles Electrodessication & Curettage - ED & C times 1 cycle Electrodessication & Curettage -
- Primary Outcome Measures
Name Time Method Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. base line, every 3 months until 12 month completion Clinical evidence of BCC recurrence post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin-Madison, Department of Dermatology
🇺🇸Madison, Wisconsin, United States