Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

Study Overview
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Brief Summary
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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.

Official Title
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Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study

Conditions
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Superficial Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: Electrodessication & Curettage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ED&C times 3 cycles<br> | Procedure: Electrodessication & Curettage<br>* Electrodessication & Curettage 1 or 3 cycles<br>|
| Active Comparator: ED & C times 1 cycle<br> | Procedure: Electrodessication & Curettage<br>* Electrodessication & Curettage 1 or 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | Clinical evidence of BCC recurrence post treatment | base line, every 3 months until 12 month completion |