Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

Superficial Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00994240
• Other study ID #: H-2007-0252
• Secondary ID: PRMC_CO08303
• Status: Terminated
• Phase: N/A
• First received: October 9, 2009
• Last updated: February 25, 2015
• Start date: May 2008
• Est. completion date: September 2013

Study information

• Verified date: February 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

Procedure:
• Electrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison, Department of Dermatology	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Dermatology Foundation, Skin Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No