Local Skin Blood FlowPBMNCT07809464
Reproducibility of Photobiomodulation Induced Changes in Local Skin Blood Flow in Healthy Subjects
A study testing Near-infrared photobiomodulation (NIR PBM) in people with Local Skin Blood Flow, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Skin Blood Flow
- What is being tested?
- Near-infrared photobiomodulation (NIR PBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Local Skin Blood Flow
- Being tested
- Near-infrared photobiomodulation (NIR PBM), Sham Placebo, Control (heat)
- Keywords
- photobiomodulation, skin microcirculation, local skin blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared photobiomodulation (NIR PBM)Device
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.
Sham PlaceboDevice
Identical device placement and treatment schedule with the LEDs deactivated. No near-infrared light was delivered.
Control (heat)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| PBM | Active comparator | Near Infrared PBM Receives: Device: Near-infrared photobiomodulation (NIR PBM) |
| Placebo | Sham comparator | Inactive light - no near infrared applied Receives: Device: Sham Placebo |
| Control | Sham comparator | Heat Control Receives: Device: Control (heat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1 and Day 2 (baseline and immediately after the 50-minute intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Apr 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Skin Blood FlowStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge, The Research Council of Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809464
- Sponsor's protocol ID
- 180559
- Other IDs
- 90647400, 294828
- Acronym
- PBM
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Photobiomodulation Induced Changes in Local Skin Blood Flow in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07809464
- Acronym / sponsor ID
- PBM / 180559
- Conditions
- Local Skin Blood Flow
- Keywords
- photobiomodulation, skin microcirculation, local skin blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge, The Research Council of Norway
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PBM | Active comparator | Device: Near-infrared photobiomodulation (NIR PBM)Near Infrared PBM |
| Placebo | Sham comparator | Device: Sham PlaceboInactive light - no near infrared applied |
| Control | Sham comparator | Device: Control (heat)Heat Control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-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. | Device | PBM |
| Sham PlaceboIdentical device placement and treatment schedule with the LEDs deactivated. No near-infrared light was delivered. | Device | Placebo |
| Control (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. | Device | Control |
Primary outcome
Reproducibility of NIR-induced change in local skin blood flow between two experimental sessions
Time frame: Day 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 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).
1 secondary outcome
change in local skin temperature relative to baseline.
Time frame: Day 1 and Day 2 (baseline and immediately after the 50-minute intervention period).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared photobiomodulation (NIR PBM) in people with Local Skin Blood Flow, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of NIR-induced change in local skin blood flow between two experimental sessions (time frame: Day 1 and Day 2 (5-minute baseline, 50-minute NIR intervention period, and 15-minute post-intervention assessment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.