Cure Rates of Superficial Basal Cell Carcinom (BCC) Following 1 Versus 3 Cycles of Electrodessication and Curettage (ED&C)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Skin Cancer Foundation
Dermatology Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00994240
First received: October 9, 2009
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Superficial Basal Cell Carcinoma
Procedure: Electrodessication & Curettage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The primary goal of the study is to determine whether there is a difference in cure rates of superficial BCC following one cycle of ED&C versus three cycles of ED&C. [ Time Frame: base line, every 3 months until 12 month completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2008
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ED&C times 3 cycles Procedure: Electrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles
Active Comparator: ED & C times 1 cycle Procedure: Electrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994240

Locations
United States, Wisconsin
University of Wisconsin-Madison, Department of Dermatology
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Skin Cancer Foundation
Dermatology Foundation
Investigators
Principal Investigator: Joyce Teng, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00994240     History of Changes
Other Study ID Numbers: H-2007-0252, PRMC_CO08303
Study First Received: October 9, 2009
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on April 17, 2014