Double-blind Randomized Controlled Study of the Effects of 5G Radiation on Skin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin
研究概览
简要总结
The current 5G waves used on the daily life are ranging from 410 MHz to 7125 MHz and are called FR1. The next deployed 5G waves will be FR2, from 24.45 GHz to 52.6 GHz. Our project targets the 27.5 GHz frequency, as it will be used in both Europe and the USA. Recent studies have shown that these 5G FR2 waves enter the skin but do not penetrate deeper in the body, which is why our project focuses on the skin.
Our aim is to understand the effects of 5G waves on skin by performing a clinical trial. In this study, participants (healthy volunteers, patients with dermatoporosis, or whose skin is prone to developing cancer or who suffer from atopic dermatitis) will be exposed to carefully chosen 5G parameters and skin will be analyzed by state-of-the-art single cell RNA analysis (an unbiased and very sensitive technique ideal for studying cell behavior changes). This project will also decipher the differences between women and men, in response to 5G FR2 waves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Computer assisted randomisation of exposure vs non exposure side
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be recruited in accordance with European and Swiss standards for the following groups: Healtyh volunteers or Dermatoporosis defined as a chronic skin fragility syndrome orGorlin Goltz Syndrome defined as OMIM 10940014, or Familial Cylindromatosis or SB Syndrome defined as OMIM 132700/60504114, or XPV defined as OMIM 27875014 or Atopic dermatitis defined as a chronic inflammatory skin disease characterised by eczematous skin lesions and intense pruritus
- •Able to give informed consent as documented by signature,
- •Adults, from 18 to 80 yo, according to groups
排除标准
- •Recent intense exposure to sun (defined as causing a sunburn, within the last 7 days)
- •Pregnant (excluded with a pregnancy test) or lactating women,
- •Patients taking anti-coagulants
- •Clinically significant concomitant diseases (cutaneous exam by the specialist),
- •Active enrolment in another clinical trial,
- •Participants incapable of judgment or participants under tutelage.
研究组 & 干预措施
Healthy volunteers 5G-FR2 exposed vs sham-exposed skin
A 5G source, only exposing a small skin-area, will be placed on each arm of the participants. Only one of the two sources will emit waves (controlled by a computer). One arm will be exposed to 20W/m2 (a dose rate inferior to the recommended maximum for EMW exposure in Switzerland), the other not (sham-exposed). The exposure time is 20 min.
干预措施: 5GFR2 non ionizing EMW exposure (Radiation)
Patients with dermatoporosis 5G-FR2 exposed vs sham-exposed skin
A 5G source, only exposing a small skin-area, will be placed on each arm of the participants. Only one of the two sources will emit waves (controlled by a computer). One arm will be exposed to 20W/m2 (a dose rate inferior to the recommended maximum for EMW exposure in Switzerland), the other not (sham-exposed). The exposure time is 20 min.
干预措施: 5GFR2 non ionizing EMW exposure (Radiation)
Patients with atopic dermatitis 5G-FR2 exposed vs sham-exposed skin
A 5G source, only exposing a small skin-area, will be placed on each arm of the participants. Only one of the two sources will emit waves (controlled by a computer). One arm will be exposed to 20W/m2 (a dose rate inferior to the recommended maximum for EMW exposure in Switzerland), the other not (sham-exposed). The exposure time is 20 min.
干预措施: 5GFR2 non ionizing EMW exposure (Radiation)
Skin-cancer prone patients 5G-FR2 exposed vs sham-exposed skin
A 5G source, only exposing a small skin-area, will be placed on each arm of the participants. Only one of the two sources will emit waves (controlled by a computer). One arm will be exposed to 20W/m2 (a dose rate inferior to the recommended maximum for EMW exposure in Switzerland), the other not (sham-exposed). The exposure time is 20 min.
干预措施: 5GFR2 non ionizing EMW exposure (Radiation)
结局指标
主要结局
Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin
时间窗: 18 month
Measure: Fold of expression of messenger RNAs, as measured by single cell RNA analysis. This is measure of the overall tissue composition and cellular activity. Further information: Inputs: ScRNAseq data from the sample, age, sex, groups, skin thickness, arm of the biopsy, 1h or 24h after exposure, concomitant medication, healing process, adverse effects. Outputs: based on our own analyses and others (ref). We will use Seurat package to perfom the quality controls of the data on individual samples, then integrate the samples for each patient to analyze their inter-variability. To determine cell types, we will combine unsupervised clustering and differential expression to compare top differentially expressed genes (using Wilcoxon rank sum tests of the FindMarker function of Seurat) with cell type specific expression known from literature. We will also use ProjecTILs package30 to define more precisely the immune subtypes.
次要结局
- Variation in expression levels of proteins expressed by skin cells, comparing healthy skin and disease-affected skin(18 month)
- Variation in expression levels of proteins expressed by skin cells, comparing female and male skin(18 month)
研究者
Prof. Olivier Gaide, MD-PhD
Associate Professor, Médecin Chef
Centre Hospitalier Universitaire Vaudois