NCT02453113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3.6 years

First QC Date

April 22, 2015

Results QC Date

April 17, 2020

Last Update Submit

October 28, 2022

Conditions

Vaccine Response Impaired

Outcome Measures

Primary Outcomes (1)

  • Change in Skin Tissue Response to a Vaccine

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

    up to 12 months

Study Arms (1)

low power laser

OTHER

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

Other: low power laser

Interventions

low power laserOTHER

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

low power laser

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men and women with skin type 1 and 2
  • Not pregnant

You may not qualify if:

  • Use of systemic steroids, topical steroids, tanning solutions and anticoagulant
  • History of HIV, mentally incompetent, prisoner, alcohol or drug impairment
  • Abnormal photosensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

Vaccine and Immunotherapy Center Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Limitations and Caveats

Small sample size

Results Point of Contact

Title
Kristen Kelly
Organization
UC Irvine
[email protected]
949 824 5515

Study Officials

  • Kristen Kelly, MD

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 25, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 1, 2022

Results First Posted

September 16, 2020

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)