The Effects of 5G Radiation on Skin

Official title

Double-blind Randomized Controlled Study of the Effects of 5G Radiation on Skin

Overview

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.

Interventions

• Radiation 5GFR2 non ionizing EMW exposure
  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. The exposure time is 20 minutes. After the exposure, the participants will wait one hour and a 7.5-mm biopsy by punch (two pieces: one 5-mm punch + half a 5-mm punch) will be performed under local anes

Primary outcome measures

• Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin [Time frame: 18 month]

Secondary outcome measures (2)

• Variation in expression levels of proteins expressed by skin cells, comparing female and male skin [Time frame: 18 month]
• Variation in expression levels of proteins expressed by skin cells, comparing healthy skin and disease-affected skin [Time frame: 18 month]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

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

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Switzerland · 1 center

• CHUV — Lausanne

Publications

• Pich-Bavastro C, Yerly L, Di Domizio J, Tissot-Renaud S, Gilliet M, Kuonen F. Activin A-Mediated Polarization of Cancer-Associated Fibroblasts and Macrophages Confers Resistance to Checkpoint Immunotherapy in Skin Cancer. Clin Cancer Res. 2023 Sep 1;29(17):3498-3513. doi: 10.1158/1078-0432.CCR-23-0219. PMID 37327314

Identifiers

NCT: NCT05933954 · CHUV-DD-00884-SEAWAVE-2023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗