Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy

NCT ID: NCT06866522

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2025-07-20

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%

Conditions

Photobiomodulation Therapy; Phototype

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Whole-body Photobiomodulation Therapy

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Lara Maria Bataglia Espósito

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of São Carlos (UFSCar)

São Carlos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Lara M Bataglia Esposito, PT

Role: primary

larabataglia@estudante.ufscar.br

+55 16 3351-8985

Other Identifiers

2023/07857-6

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

70368823.8.0000.5504

Identifier Type: -

Identifier Source: org_study_id