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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beckman Laser Institute University of California Irvine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low power laser | Other | Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low power laser | Other | Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Tissue Response to a Vaccine | Change in inflammatory cells with low level laser will be measured. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Kelly, MD | Beckman Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Laser Institute | Irvine | California | 92612 | United States | ||
| Vaccine and Immunotherapy Center Massachusetts General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Skin Tissue Response to a Vaccine | Change in inflammatory cells with low level laser will be measured. | 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. | Posted | Mean | Standard Error | Total number of CD1a+ cells (5hpf) | up to 12 months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Kelly | UC Irvine | 949 824 5515 | kmkelly@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 15, 2017 | Apr 17, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Charlestown |
| Massachusetts |
| 02129 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
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| Participants |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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