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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02453113
• Collaborator: Massachusetts General Hospital (Other), Beckman Laser Institute University of California Irvine (Other)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Duration (Months): 43
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Response Impaired	Other: low power laser	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Skin Tissue Response to a Vaccine [up to 12 months]

   Change in inflammatory cells with low level laser will be measured.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Beckman Laser Institute	Irvine	California	United States	92612
2	Vaccine and Immunotherapy Center Massachusetts General Hospital	Charlestown	Massachusetts	United States	02129

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

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 15, 2017

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: NIH/LAMMP-2015-1840
• First Posted: May 25, 2015
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Low Power Laser
Arm/Group Description	Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Low Power Laser
Arm/Group Description	Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	41
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

We expect to demonstrate that the NIR laser dose elicits statistically significant dendritic cell trafficking to the human skin and induces cytokine/chemokine release and expression changes similar to that previously seen in mice.

Arm/Group Title	Low Power Laser
Arm/Group Description	Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Measure Participants	10
Epidermis CD1a+ Langerhans cells Normal Control	39.0 (1.6)
Epidermis CD1a+ Langerhans cells Cases	36.1 (1.6)
Dermis CD1a+ Langerhans cells Normal Control	21.5 (2.0)
Dermis CD1a+ Langerhans cells Cases	11.8 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Low Power Laser
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.

Adverse Events

Time Frame	1 year
Arm/Group Title	Low Power Laser
Arm/Group Description	Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
All Cause Mortality
	Low Power Laser
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Low Power Laser
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Low Power Laser
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

Small sample size

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.