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Clinical Trials/NCT06866522
NCT06866522RecruitingNot Applicable

Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy: Clinical Trial

Universidade Federal de Sao Carlos1 site in 1 country72 target enrollmentStarted: November 27, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Light Reflection

Study Overview

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%

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Whole-body Photobiomodulation Therapy (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Universidade Federal de Sao Carlos
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lara Maria Bataglia Espósito

Principal Investigator

Universidade Federal de Sao Carlos

Study Sites (1)

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