Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
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Details and patient eligibility
About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
85 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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