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

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Vaccine and Immunotherapy Center Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Tissue Response to a Vaccine
Time Frame: up to 12 months
Change in inflammatory cells with low level laser will be measured.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Massachusetts General Hospital
Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Kristen Kelly, MD, Beckman Laser Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20151840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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