Optical Biopsy of Human Skin in Conjunction With Laser Treatment

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00540566

First Posted: October 8, 2007

Last Update Posted: February 10, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Beckman Laser Institute University of California Irvine

Information provided by (Responsible Party):

Beckman Laser Institute and Medical Center, University of California, Irvine

Purpose

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	Intervention
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


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Resource links provided by NLM:

MedlinePlus related topics: Biopsy

Genetic and Rare Diseases Information Center resources: Merkel Cell Carcinoma Systemic Scleroderma Soft Tissue Sarcoma Kaposi Sarcoma Tylosis Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:

normal skin [ Time Frame: 12 weeks ]


Enrollment:	113
Study Start Date:	June 1999
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Optical Biopsy Optical Biopsy imaging	Device: Optical Biopsy imaging 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.

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	October 4, 2007
First Posted:	October 8, 2007
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

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