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

Vaccine Response Impaired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453113
• Other study ID #: 20151840
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2019

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaccine Response Impaired

Intervention

Other:
• low power laser
Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Locations

Country	Name	City	State
United States	Vaccine and Immunotherapy Center Massachusetts General Hospital	Charlestown	Massachusetts
United States	Beckman Laser Institute	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Tissue Response to a Vaccine	Change in inflammatory cells with low level laser will be measured.	up to 12 months