Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
NCT00994240 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2015-02-27
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.
Conditions
- Superficial Basal Cell Carcinoma
Interventions
- PROCEDURE
-
Electrodessication & Curettage
Electrodessication \& Curettage 1 or 3 cycles
Sponsors & Collaborators
-
Skin Cancer Foundation
collaborator UNKNOWN -
Dermatology Foundation
collaborator OTHER -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Eric Berg, MD · University of Wisconsin, Madison
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-09-30
Countries
- United States
Study Locations
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