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Recruiting NCT06866522

Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy

No phase Interventional Photobiomodulation Therapy Phototype

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole-body Photobiomodulation Therapy.
Who it may be relevant to
Registry conditions: Photobiomodulation Therapy, Phototype. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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%

Interventions

  • 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.

Primary outcome measures

  • Light Reflection [Time frame: Acute measurement. The measurement will be performed just during the light therapy irradiation, on the day of the procedure.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Brazil · 1 center
  • Federal University of São Carlos (UFSCar) — São Carlos

Identifiers

NCT: NCT06866522 · 70368823.8.0000.5504 · 2023/07857-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗