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

Not Applicable

Completed

• Conditions: Vaccine Response Impaired
• Interventions: Other: low power laser

• Registration Number: NCT02453113
• Lead Sponsor: University of California, Irvine

Brief 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.

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 Timeline

• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-25
• Study Start: 2015-06
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Results First Submitted: 2020-04-17
• Results First Submitted QC: 2020-08-27
• Results First Posted: 2020-09-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
low power laser	low power laser	Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Primary Outcome Measures

Name	Time	Method
Change in Skin Tissue Response to a Vaccine	up to 12 months	Change in inflammatory cells with low level laser will be measured.

Trial Locations

Locations (2)

Beckman Laser Institute; 🇺🇸 Irvine, California, United States

Vaccine and Immunotherapy Center Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States