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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07809464
Acronym
PBM
Enrollment
16
Registered
2026-09-09
Start date
2022-04-01
Completion date
2023-10-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Skin Blood Flow

Keywords

photobiomodulation, skin microcirculation, local skin blood flow

Brief 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.

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.

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.

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER
Helse Midt-Norge
CollaboratorOTHER
The Research Council of Norway
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility of NIR-induced change in local skin blood flow between two experimental sessionsDay 1 and Day 2 (5-minute baseline, 50-minute NIR intervention period, and 15-minute post-intervention assessment).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 %change in skin blood flow relative to baseline. Reproducibility was assessed by comparing the %change from baseline between the two experimental sessions following the same protocol (Day1 Vs Day2).

Secondary

MeasureTime frameDescription
change in local skin temperature relative to baseline.Day 1 and Day 2 (baseline and immediately after the 50-minute intervention period).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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026