Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Skin Imaging With Technologies in Development

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00764920
First received: September 30, 2008
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studies include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.


Condition Intervention
Pigmented Skin Lesion of Uncertain Nature
Device: non-invasive imaging modalities for assessment of skin

Study Type: Observational
Official Title: Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Collect information on normal and lesional skin [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    Develop non-invasive imaging modalities for assessment of skin.


Estimated Enrollment: 350
Study Start Date: October 2008
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Skin Imaging
non-invasive imaging modalities for assessment of skin
Device: non-invasive imaging modalities for assessment of skin
skin imaging
Other Name: non-invasive imaging modalities for assessment of skin

Detailed Description:

Normal and lesional skin will be assessed by the following imaging modalities:

  1. Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.
  2. Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.
  3. Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.
  4. Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.
  5. Multiphoton Microscopy can provide structures of the skin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study population will be selected from University of California Irvine Medical Clinic

Criteria

Inclusion Criteria:

  • adult male or female 18 years of age or older

Exclusion Criteria:

  • Younger than 18 years old
  • pregnant woman
  • breast feeding
  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: NCT00764920

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen M Kelly, MD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00764920     History of Changes
Other Study ID Numbers: NIH/LAMMP-2008-6307
Study First Received: September 30, 2008
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
human skin

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014