Trial Outcomes & Findings for Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment (NCT NCT02453113)

NCT ID: NCT02453113

Last Updated: 2022-11-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

up to 12 months

Results posted on

2022-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Low Power Laser 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 Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Power Laser n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Low Power Laser n=10 Participants 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
Change in Skin Tissue Response to a Vaccine Epidermis CD1a+ Langerhans cells Normal Control	39.0 Total number of CD1a+ cells (5hpf) Standard Error 1.6
Change in Skin Tissue Response to a Vaccine Epidermis CD1a+ Langerhans cells Cases	36.1 Total number of CD1a+ cells (5hpf) Standard Error 1.6
Change in Skin Tissue Response to a Vaccine Dermis CD1a+ Langerhans cells Normal Control	21.5 Total number of CD1a+ cells (5hpf) Standard Error 2.0
Change in Skin Tissue Response to a Vaccine Dermis CD1a+ Langerhans cells Cases	11.8 Total number of CD1a+ cells (5hpf) Standard Error 1.6

Adverse Events

Low Power Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristen Kelly

UC Irvine

Phone: 949 824 5515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place