Photobiomodulation TherapyNCT06866522
Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy
A study testing Whole-body Photobiomodulation Therapy in people with Photobiomodulation Therapy and Phototype, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Photobiomodulation Therapy, Phototype
- What is being tested?
- Whole-body Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Nov 2023to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female
- age between 18 and 30 years
- body mass index (BMI) between 18.5 and 29.9 kg/m2.
Who cannot join
- tattoo in the light reflection assessment areas
- history of skin cancer
- skin lesions such as open wounds in the mid-thigh, abdomen, biceps brachii, back and calf
- patients with cognitive difficulty reporting thermal sensation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of São Carlos (UFSCar)
São Carlos, São Paulo, 13565-905
Lara M Bataglia Esposito, PT, +55 16 3351-8985, larabataglia@estudante.ufscar.br
About this study
Official title: Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy: Clinical Trial
Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. In this context, the amount of reflected light in PBMT applied without skin contact, as well as the influence of skin phototype, has not yet been established. Objective: To quantify the reflection of light from PBMT on the skin of men and women aged 18 to 30 years, considering skin phototypes. Methodology: Participants will be divided into three groups based on skin phototype (Group 1: phototypes I and II; Group 2: phototypes III and IV; Group 3: phototypes V and VI) and sex. They will be subjected to whole-body PBMT with red light (660 nm; 31.85±3.85 mW; 45.50±5.07 mW/cm²) and infrared light (850 nm; 25.29±2.99 mW; 36.13±4.27 mW/cm²) at 20 cm from the light-emitting source, with measurement of light reflection in the regions of the brachial biceps, abdomen, lumbar, anterior and posterior thigh, and calf using a power and energy analyzer (powermeter PM100D and sensor S130C, 0.7 cm²). Data will be analyzed for normality and groups were compared with a significance level of 5%
- Conditions
- Photobiomodulation Therapy, Phototype
- Being tested
- Whole-body Photobiomodulation Therapy
- Keywords
- photobiomodulation, low-level laser therapy, skin optics, melanin, light reflection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body Photobiomodulation TherapyDevice
Whole-body Photobiomodulation Therapy applied for approximately 10 minutes, being 5 minutes with the red wavelength and 5 minutes with the infrared wavelength.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Reflection Group | Experimental | This group received measures of the light reflection using a whole-body photobiomodulation therapy with a Joovv device. In this group, participants were subclassified with the Fitzpatrick scale for their phototypes. Receives: Device: Whole-body Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light Reflection
Light reflection will be measured in mW with a PowerMeter Device in the angles of 30º, 60º and 90º considering the participant in front of the whole-body photobiomodulation therapy device.
Measured: Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start27 Nov 2023
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photobiomodulation TherapyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Maria Bataglia Espósito, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866522
- Sponsor's protocol ID
- 70368823.8.0000.5504
- Other IDs
- 2023/07857-6, 2023
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy: Clinical Trial
- ClinicalTrials.gov ID
- NCT06866522
- Acronym / sponsor ID
- 70368823.8.0000.5504
- Conditions
- Photobiomodulation Therapy, Phototype
- Keywords
- photobiomodulation, low-level laser therapy, skin optics, melanin, light reflection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 10 Mar 2025 (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.
Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. In this context, the amount of reflected light in PBMT applied without skin contact, as well as the influence of skin phototype, has not yet been established. Objective: To quantify the reflection of light from PBMT on the skin of men and women aged 18 to 30 years, considering skin phototypes. Methodology: Participants will be divided into three groups based on skin phototype (Group 1: phototypes I and II; Group 2: phototypes III and IV; Group 3: phototypes V and VI) and sex. They will be subjected to whole-body PBMT with red light (660 nm; 31.85±3.85 mW; 45.50±5.07 mW/cm²) and infrared light (850 nm; 25.29±2.99 mW; 36.13±4.27 mW/cm²) at 20 cm from the light-emitting source, with measurement of light reflection in the regions of the brachial biceps, abdomen, lumbar, anterior and posterior thigh, and calf using a power and energy analyzer (powermeter PM100D and sensor S130C, 0.7 cm²). Data will be analyzed for normality and groups were compared with a significance level of 5%
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Reflection Group | Experimental | Device: Whole-body Photobiomodulation TherapyThis group received measures of the light reflection using a whole-body photobiomodulation therapy with a Joovv device. In this group, participants were subclassified with the Fitzpatrick scale for their phototypes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male and female
- age between 18 and 30 years
- body mass index (BMI) between 18.5 and 29.9 kg/m2.
Key exclusion criteria (4 listed)
- tattoo in the light reflection assessment areas
- history of skin cancer
- skin lesions such as open wounds in the mid-thigh, abdomen, biceps brachii, back and calf
- patients with cognitive difficulty reporting thermal sensation
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 |
|---|---|---|
| Whole-body Photobiomodulation TherapyWhole-body Photobiomodulation Therapy applied for approximately 10 minutes, being 5 minutes with the red wavelength and 5 minutes with the infrared wavelength. | Device | Photobiomodulation Reflection Group |
Primary outcome
Light Reflection
Time frame: Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.
Light reflection will be measured in mW with a PowerMeter Device in the angles of 30º, 60º and 90º considering the participant in front of the whole-body photobiomodulation therapy device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
Federal University of São Carlos (UFSCar)
São Carlos, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body Photobiomodulation Therapy in people with Photobiomodulation Therapy and Phototype, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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 Brazil. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light Reflection (time frame: Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.). 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 12 Mar 2025.