Optical Biopsy of Human Skin in Conjunction With Laser Treatment

This study has been completed.

Sponsor:

Collaborator:

Beckman Laser Institute University of California Irvine

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT00540566

First received: October 4, 2007

Last updated: August 5, 2015

Last verified: August 2015

History of Changes

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:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Biopsy Birthmarks Moles

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma Malignant Mesenchymal Tumor Soft Tissue Sarcoma Merkel Cell Carcinoma Tylosis Kaposi Sarcoma Keratosis, Seborrheic Dermatofibroma Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

normal skin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 4, 2007
Last Updated:	August 5, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Carcinoma Carcinoma, Squamous Cell Keratosis Melanoma Carcinoma, Basal Cell Hemangioma Sarcoma, Kaposi Port-Wine Stain Hemangioma, Capillary Carcinoma, Merkel Cell 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 Neoplasms, Vascular Tissue Herpesviridae Infections DNA Virus Infections Virus Diseases Sarcoma Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on September 28, 2016

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