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A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions (Dermacorder)

This study has been completed.
Information provided by:
Children's Hospital & Research Center Oakland Identifier:
First received: November 16, 2009
Last updated: August 2, 2011
Last verified: August 2011
The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.

Basal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

Resource links provided by NLM:

Further study details as provided by Children's Hospital & Research Center Oakland:

Estimated Enrollment: 30
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:
The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males and females with multiple basal cell carcinomas

Inclusion Criteria:

  • Study subjects must have had diagnosed at least one benign or malignant skin lesion;
  • Subject is from 18-75 years of age, inclusive;
  • Subject must sign and date all informed consent statements.

Exclusion Criteria:

  • Subject is exhibiting signs of a bacterial or viral infection, including fever;
  • Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
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Please refer to this study by its identifier: NCT01014819

United States, California
Childrens Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Principal Investigator: Ervin Epstein, M.D. Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Ervin Epstein, MD Scientist, Children's Hospital & Research Center Oakland Identifier: NCT01014819     History of Changes
Other Study ID Numbers: 2009-36
Study First Received: November 16, 2009
Last Updated: August 2, 2011

Keywords provided by Children's Hospital & Research Center Oakland:
Electric field
basal cell carcinoma
Gorlin Syndrome

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell processed this record on May 25, 2017