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Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

NCT ID: NCT00994240

Last Updated: 2015-02-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Superficial Basal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ED&C times 3 cycles

Group Type ACTIVE_COMPARATOR

Electrodessication & Curettage

Intervention Type PROCEDURE

Electrodessication \& Curettage 1 or 3 cycles

ED & C times 1 cycle

Group Type ACTIVE_COMPARATOR

Electrodessication & Curettage

Intervention Type PROCEDURE

Electrodessication \& Curettage 1 or 3 cycles

Interventions

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Electrodessication & Curettage

Electrodessication \& Curettage 1 or 3 cycles

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Skin Cancer Foundation

UNKNOWN

Sponsor Role collaborator

Dermatology Foundation

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Berg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison, Department of Dermatology

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PRMC_CO08303

Identifier Type: OTHER

Identifier Source: secondary_id

H-2007-0252

Identifier Type: -

Identifier Source: org_study_id