NCT00994240

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

5.3 years

First QC Date

October 9, 2009

Results QC Date

December 5, 2014

Last Update Submit

February 25, 2015

Conditions

Superficial Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ED&C times 3 cycles

ACTIVE COMPARATOR
Procedure: Electrodessication & Curettage

ED & C times 1 cycle

ACTIVE COMPARATOR
Procedure: Electrodessication & Curettage

Interventions

Electrodessication & CurettagePROCEDURE

Electrodessication \& Curettage 1 or 3 cycles

ED & C times 1 cycleED&C times 3 cycles

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison, Department of Dermatology

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Interventions

Curettage

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

Title
Clinical Research Administrator
Organization
University of Wisconsin-Madison
dbock@dermatology.wisc.edu
608-287-2640

Study Officials

  • Eric Berg, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 14, 2009

Study Start

May 1, 2008

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

February 27, 2015

Results First Posted

February 27, 2015

Record last verified: 2015-02

Locations

US(1)