Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy

March 7, 2025 updated by: Lara Maria Bataglia Espósito, Universidade Federal de Sao Carlos

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%

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Carlos, SP, Brazil, 13565-905
        • Recruiting
        • Federal University of São Carlos (UFSCar)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photobiomodulation Reflection Group
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
Whole-body Photobiomodulation Therapy applied for approximately 10 minutes, being 5 minutes with the red wavelength and 5 minutes with the infrared wavelength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Estimated)

March 20, 2025

Study Completion (Estimated)

July 20, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 70368823.8.0000.5504
  • 2023/07857-6 (Other Grant/Funding Number: FAPESP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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