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CompletedNCT07809464PBMUpdated Sep 15, 2026

Reproducibility of Photobiomodulation Induced Changes in Local Skin Blood Flow in Healthy Subjects

An interventional study of Near-infrared photobiomodulation (NIR PBM) and Sham Placebo in Local Skin Blood Flow, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study investigated whether near-infrared photobiomodulation (PBM), a non-invasive light therapy, can consistently increase blood flow in the skin of healthy adults. Participants attended two identical study sessions in which they received both active PBM treatment and a placebo treatment using the same device with the light turned off. A subgroup of participants also completed a heat-control session to determine whether any changes in blood flow were caused by the light itself or by heat from the device.

02

Conditions studied

  • Local Skin Blood Flow

Keywords

  • photobiomodulation
  • skin microcirculation
  • local skin blood flow
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults aged 18 to 50 years.
  • In good general health.
  • No reported illness during the 3 months preceding enrollment.
  • Able and willing to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Clinically unstable chronic disease.
  • Chronic dermatological conditions.
  • Any medical condition that, in the opinion of the study physician, would make participation unsafe or interfere with study procedures.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    PBM

    Near Infrared PBM

    Device: Near-infrared photobiomodulation (NIR PBM)

  • Sham comparator
    Placebo

    Inactive light - no near infrared applied

    Device: Sham Placebo

  • Sham comparator
    Control

    Heat Control

    Device: Control (heat)

Interventions

  • DeviceNear-infrared photobiomodulation (NIR PBM)

    Near-infrared photobiomodulation delivered using a modified Anodyne® Therapy System (Model 120). Device parameters included 890 nm wavelength, irradiance of 5.1 mW/cm², radiant exposure of 4.6 J/cm² and total radiant energy of 35.9 J. The intervention consisted of ten cycles of 3 minutes ON followed by 2-minute OFF intervals.

  • DeviceSham Placebo

    Identical device placement and treatment schedule with the LEDs deactivated. No near-infrared light was delivered.

  • DeviceControl (heat)

    The modified device was wrapped in aluminium foil to prevent near-infrared light from reaching the skin while allowing conductive heat transfer. The protocol was otherwise identical to the active intervention.

05

What researchers measure

Primary outcomes

  1. Reproducibility of NIR-induced change in local skin blood flow between two experimental sessions

    Local skin blood flow was measured using laser Doppler flowmetry and expressed as blood perfusion units (BPU). A 5-minute baseline measurement was obtained before exposure. This was followed by ten consecutive 5-minute cycles, consisting of 3 minutes of near-infrared (NIR) exposure followed by 2 minutes without NIR exposure, during which skin blood flow was recorded. After completion of the tenth cycle (50 minutes), NIR exposure was discontinued and skin blood flow was recorded for an additional 15 minutes to assess if the blood flow response lasts post NIR exposure. The outcome was expressed as percent change in skin blood flow relative to baseline. Reproducibility was assessed by comparing the percent change from baseline between the two experimental sessions following the same protocol (Day1 Vs Day2).

    Time frame: Day 1 and Day 2 (5-minute baseline, 50-minute NIR intervention period, and 15-minute post-intervention assessment).

Secondary outcomes

  1. change in local skin temperature relative to baseline.

    Local skin temperature was measured at the intervention site before the start of the intervention and immediately after completion of the 50-minute intervention period. The change in local skin temperature was calculated relative to the baseline measurement. Measurements were performed using the same protocol on Day 1 and Day 2.

    Time frame: Day 1 and Day 2 (baseline and immediately after the 50-minute intervention period).

06

Study locations

1 site
  • NTNU, St Olavs Hospital
    Trondheim, Norway
07

Registry details

Key details

Study ID
NCT07809464
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Helse Midt-Norge, The Research Council of Norway
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Apr 1, 2022
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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