Electromagnetic Radiation (5GFR2)SEAwaveNCT05933954
The Effects of 5G Radiation on Skin
A study testing 5GFR2 non ionizing EMW exposure in people with Electromagnetic Radiation (5GFR2), run by Prof. Olivier Gaide, MD-PhD at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electromagnetic Radiation (5GFR2)
- What is being tested?
- 5GFR2 non ionizing EMW exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jan 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Olivier Gaide, MD-PhD, +41213140111, olivier.gaide@chuv.ch
Christine Pich, PhD, christine.pich@chuv.ch
About this study
Official title: Double-blind Randomized Controlled Study of the Effects of 5G Radiation on Skin
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.
- Conditions
- Electromagnetic Radiation (5GFR2)
- Being tested
- 5GFR2 non ionizing EMW exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5GFR2 non ionizing EMW exposureRadiation
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 anesthesia on each arm. The wound will be closed by a simple suture. A second set of samples will be taken 24h after the exposure, using the same procedure.
For each participant, 1 full biopsy per arm and per time-point will be used for single-cell-RNA-sequencing analysis. The selected method uses generic probed sequencing and does not generate patient-specific genomic information.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers 5G-FR2 exposed vs sham-exposed skin | Other | 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. Receives: Radiation: 5GFR2 non ionizing EMW exposure |
| Patients with dermatoporosis 5G-FR2 exposed vs sham-exposed skin | Other | 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. Receives: Radiation: 5GFR2 non ionizing EMW exposure |
| Patients with atopic dermatitis 5G-FR2 exposed vs sham-exposed skin | Other | 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. Receives: Radiation: 5GFR2 non ionizing EMW exposure |
| Skin-cancer prone patients 5G-FR2 exposed vs sham-exposed skin | Other | 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. Receives: Radiation: 5GFR2 non ionizing EMW exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin
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.
Measured: 18 month
Secondary outcomes (2)
Variation in expression levels of proteins expressed by skin cells, comparing female and male skin
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. For further details, see primary outcome.
Measured: 18 month
Variation in expression levels of proteins expressed by skin cells, comparing healthy skin and disease-affected skin
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. For further details, see primary outcome.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start9 Jan 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electromagnetic Radiation (5GFR2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Olivier Gaide, MD-PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Olivier Gaide, MD-PhD, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933954
- Sponsor's protocol ID
- CHUV-DD-00884-SEAWAVE-2023
- Acronym
- SEAwave
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37327314
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Controlled Study of the Effects of 5G Radiation on Skin
- ClinicalTrials.gov ID
- NCT05933954
- Acronym / sponsor ID
- SEAwave / CHUV-DD-00884-SEAWAVE-2023
- Conditions
- Electromagnetic Radiation (5GFR2)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Prof. Olivier Gaide, MD-PhDUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers 5G-FR2 exposed vs sham-exposed skin | Other | Radiation: 5GFR2 non ionizing EMW exposureA 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. |
| Patients with dermatoporosis 5G-FR2 exposed vs sham-exposed skin | Other | Radiation: 5GFR2 non ionizing EMW exposureA 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. |
| Patients with atopic dermatitis 5G-FR2 exposed vs sham-exposed skin | Other | Radiation: 5GFR2 non ionizing EMW exposureA 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. |
| Skin-cancer prone patients 5G-FR2 exposed vs sham-exposed skin | Other | Radiation: 5GFR2 non ionizing EMW exposureA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5GFR2 non ionizing EMW exposureA 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 anesthesia on each arm. The wound will be closed by a simple suture. A second set of samples will be taken 24h after the exposure, using the same procedure. For each participant, 1 full biopsy per arm and per time-point will be used for single-cell-RNA-sequencing analysis. The selected method uses generic probed sequencing and does not generate patient-specific genomic information. | Radiation | Healthy volunteers 5G-FR2 exposed vs sham-exposed skin, Patients with atopic dermatitis 5G-FR2 exposed vs sham-exposed skin, Patients with dermatoporosis 5G-FR2 exposed vs sham-exposed skin, Skin-cancer prone patients 5G-FR2 exposed vs sham-exposed skin |
Primary outcome
Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 37327314Pich-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5GFR2 non ionizing EMW exposure in people with Electromagnetic Radiation (5GFR2), run by Prof. Olivier Gaide, MD-PhD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in expression levels of proteins expressed by skin cells, comparing exposed and non-exposed skin (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.