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Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02453113
First Posted: May 25, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
The purpose of this is that the researcher can use low power Near Infrared laser treatment non-painful and non-damaging dose to changes the skin properties.The researcher can prove that signaling and a significant increase in the number of skin cells in skin tissue exposed to the laser can improve the human skin immune system to help improve human body response to vaccines.

Condition Intervention Phase
Vaccine Response Impaired Other: low power laser Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment

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

Primary Outcome Measures:
  • Increase the skin tissue to response to a vaccine [ Time Frame: up to 12 months ]

Estimated Enrollment: 10
Study Start Date: June 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
low power laser
Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Other: low power laser
Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Detailed Description:

The researcher can use low power laser light one-minute exposures delivered to the skin at non-painful and non-damaging dose. The resulted in significant immunologic changes in the skin that included up-regulation of specific skin tissue and skin genes and the activation and mobilization of specific skin cells.

In the first part of the study, the researcher will make a determination of the laser irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute will be identified as that subject's maximum tolerable irradiance. After all subjects are tested, researcher will select the highest irradiance that was tolerated and use this in the second phase of the study.

Approximately 24 hours after the first test exposures, each subject will receive a one minute laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will be collected from laser treated site a untreated.

One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate RNA and protein expression.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult men and women with skin type 1 and 2
  • Not pregnant

Exclusion Criteria:

  • Use of systemic steroids, topical steroids, tanning solutions and anticoagulant
  • History of HIV, mentally incompetent, prisoner, alcohol or drug impairment
  • Abnormal photosensitivity
  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): NCT02453113


Contacts
Contact: Brent Martin, MD 949.233-9060 bcmartin@uci.edu

Locations
United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Brent Martin, MD    949-233-9060    bcmartin@uci.edu   
Contact: Logan Thomas, MD       lwthomas@uci.edu   
Principal Investigator: Kristen Kelly, MD         
Sub-Investigator: Brent Martin, MD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Kristen Elkins, MD         
Sub-Investigator: Logan Thomas, MS2         
Sub-Investigator: Kathryn Osann, PhD         
United States, Massachusetts
Vaccine and Immunotherapy Center Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Jeffrey Gelfand, MD    617-726-1796    jgelfand@mgh.harvard.edu   
Sub-Investigator: Jeffery Gelfand, MD         
Sub-Investigator: Rosalynn M Nazarian, MD         
Sponsors and Collaborators
University of California, Irvine
Massachusetts General Hospital
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02453113     History of Changes
Other Study ID Numbers: NIH/LAMMP-2015-1840
First Submitted: April 22, 2015
First Posted: May 25, 2015
Last Update Posted: February 10, 2017
Last Verified: February 2017