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
  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:


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
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

No publications provided

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, Basal Cell
Carcinoma, Merkel Cell
Carcinoma, Squamous Cell
Hemangioma
Histiocytoma
Keratosis, Seborrheic
Melanoma
Port-Wine Stain
Sarcoma, Kaposi
Adenocarcinoma
Carcinoma, Neuroendocrine
Congenital Abnormalities
DNA Virus Infections
Herpesviridae Infections
Keratosis
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Squamous Cell
Neoplasms, Vascular Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 31, 2015