Clinical trial NCT00994240: Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
Official title: Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Superficial Basal Cell Carcinoma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Skin Cancer Foundation
name: Dermatology Foundation
First posted: 2009-10-14
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
timeFrame: base line, every 3 months until 12 month completion
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison, Department of Dermatology
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Eric Berg, MD
role: PRINCIPAL_INVESTIGATOR
References: