NCT06866522

Brief 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. 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%

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

February 28, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

photobiomodulationlow-level laser therapyskin opticsmelaninlight reflection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.

Study Arms (1)

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.

Device: Whole-body Photobiomodulation Therapy

Interventions

Whole-body Photobiomodulation Therapy applied for approximately 10 minutes, being 5 minutes with the red wavelength and 5 minutes with the infrared wavelength.

Photobiomodulation Reflection Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female
  • age between 18 and 30 years
  • body mass index (BMI) between 18.5 and 29.9 kg/m2.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Carlos (UFSCar)

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 10, 2025

Study Start

November 27, 2023

Primary Completion

March 20, 2025

Study Completion

July 20, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations