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

NCT ID: NCT02453113

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-01-31

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.

Conditions

Vaccine Response Impaired

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

low power laser

Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Group Type: OTHER

low power laser

Intervention Type: OTHER

Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Interventions

low power laser

Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute

Locations

Beckman Laser Institute

Irvine, California, United States

Vaccine and Immunotherapy Center Massachusetts General Hospital

Charlestown, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

20151840

Identifier Type: -

Identifier Source: org_study_id