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Skin Imaging With Technologies in Development

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ClinicalTrials.gov Identifier: NCT00764920
Recruitment Status : Recruiting
First Posted : October 2, 2008
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Kristen Kelly, University of California, Irvine

Tracking Information
First Submitted Date September 30, 2008
First Posted Date October 2, 2008
Last Update Posted Date June 29, 2022
Study Start Date October 2008
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2014)		 Collect information on normal and lesional skin [ Time Frame: up to 12 weeks ]
Develop non-invasive imaging modalities for assessment of skin.
Original Primary Outcome Measures
 (submitted: October 1, 2008)		 Learn information about the human skin which could be useful for diagnosis or guiding treatment. [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Skin Imaging With Technologies in Development
Official Title Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin
Brief Summary 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 studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.
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 images of structures of the skin.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population will be selected from University of California Irvine Medical Clinic
Condition Pigmented Skin Lesion of Uncertain Nature
Intervention Device: non-invasive imaging modalities for assessment of skin
skin imaging
Study Groups/Cohorts Skin Imaging
non-invasive imaging modalities for assessment of skin
Intervention: Device: non-invasive imaging modalities for assessment of skin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 4, 2021)		 750
Original Estimated Enrollment
 (submitted: October 1, 2008)		 500
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult male or female 7 and older; able to carry out study instructions

Exclusion Criteria:

  • Younger than 7 years old
  • pregnant woman
  • breast feeding
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hanna Kim, MA 949-824-9265 hhkim3@uci.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00764920
Other Study ID Numbers 20086307
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Kristen Kelly, University of California, Irvine
Original Responsible Party Kristen Kelly, Beckman Laser Institute
Current Study Sponsor University of California, Irvine
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Kristen M Kelly, MD Beckman Laser Institute University of California Irvine
PRS Account University of California, Irvine
Verification Date June 2022