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Optical Biopsy of Human Skin in Conjunction With Laser Treatment

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ClinicalTrials.gov Identifier: NCT00540566
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

Condition or disease Intervention/treatment
Malignant Melanoma Merkel Cell Carcinoma Basal Cell Carcinoma Squamous Cell Carcinoma Atypical Nevi Congenital Nevi Seborrheic Keratosis Paget's Disease Dermatofibroma Kaposi's Sarcoma Port Wine Stain Hemangioma Tattoos Scleroderma Burns Device: Optical Biopsy imaging

Detailed Description:
The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Study Start Date : June 1999
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Optical Biopsy
Optical Biopsy imaging
 Device: Optical Biopsy imaging
Optical Biopsy imaging


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. normal skin [ Time Frame: 12 weeks ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, community sample
Criteria

Inclusion Criteria:

  • Male or female age > 18 years

Exclusion Criteria:

  • current participation in any other investigational drug evaluation
  • inability to understand and carry out instructions
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540566


Locations
United States, California
Beckman Laser Institute, Unversity of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: John S Nelson, M.D,Ph.D Beckman Laser Institue, University of California Irvine
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540566     History of Changes
Other Study ID Numbers: NIH-LAMPP-1996-200
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Keratosis
Melanoma
Carcinoma, Basal Cell
Sarcoma, Kaposi
Hemangioma
Nevus
Carcinoma, Merkel Cell
Port-Wine Stain
Hemangioma, Capillary
Keratosis, Seborrheic
Histiocytoma, Benign Fibrous
Histiocytoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Basal Cell
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue