Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Light Reflection
研究概览
简要总结
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%
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female
- •age between 18 and 30 years
- •body mass index (BMI) between 18.5 and 29.9 kg/m2.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Whole-body Photobiomodulation Therapy (Device)
结局指标
主要结局
Light Reflection
时间窗: 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.
次要结局
未报告次要终点
研究者
Lara Maria Bataglia Espósito
Principal Investigator
Universidade Federal de Sao Carlos
