UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060456 |
|---|---|
| Receipt number | R000069174 |
| Scientific Title | Evaluation of the Effects of Combined 5G Radiofrequency Exposure on Human Skin |
| Date of disclosure of the study information | 2026/01/24 |
| Last modified on | 2026/01/25 10:02:00 |
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Basic information
Public title
Evaluation of the Effects of Combined 5G Radiofrequency Exposure on Human Skin
Acronym
Evaluation of the Effects of Combined 5G Radiofrequency Exposure on Human Skin
Scientific Title
Evaluation of the Effects of Combined 5G Radiofrequency Exposure on Human Skin
Scientific Title:Acronym
Evaluation of the Effects of Combined 5G Radiofrequency Exposure on Human Skin
Region
| Japan |
Condition
Condition
None (healthy volunteers only)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to characterize the physiological responses of human skin to radiofrequency exposure at 28 GHz and 2 GHz, focusing on changes in skin temperature, skin blood flow, thermal sensation, and stress-related biomarkers. In addition, the study seeks to clarify whether simultaneous exposure to multiple frequencies produces physiological responses that differ from those induced by single-frequency exposure, thereby providing biological evidence to support the scientific basis of international radiofrequency exposure guidelines.
Basic objectives2
Others
Basic objectives -Others
- To quantify changes in skin surface temperature during and after exposure to 28 GHz and 2 GHz radiofrequency fields.
- To evaluate changes in skin blood flow associated with radiofrequency exposure.
- To assess subjective thermal sensation during radiofrequency exposure.
- To examine changes in stress-related biomarkers before and after radiofrequency exposure.
- To compare physiological responses between single-frequency exposure and combined multi-frequency exposure conditions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measure is the maximum change in skin surface temperature (change in skin temperature) of the dorsal skin during 5G millimeter wave exposure.
Skin temperature is continuously measured before exposure, during exposure, and immediately after exposure, and the maximum change from baseline is calculated.
This outcome is assessed under single-frequency exposure at 28 GHz or 2 GHz, as well as under combined exposure to both frequencies.
Key secondary outcomes
1. Time course of skin surface temperature during and after radiofrequency exposure
Skin surface temperature is continuously measured before exposure, during exposure, and for a defined period after exposure to evaluate temporal changes relative to baseline.
2. Changes in skin blood flow during and after radiofrequency exposure
Skin blood flow at the exposure site is measured before exposure, during exposure, and after exposure, and changes from baseline are evaluated.
3. Subjective assessment of thermal sensation during radiofrequency exposure
Thermal sensation is assessed using self-reported thermal sensation scores collected during exposure and immediately after exposure.
4. Changes in stress-related biomarkers before and after radiofrequency exposure
Stress-related biomarkers (e.g., salivary cortisol) are measured using biological samples collected before and after exposure, and changes are evaluated.
5. Comparison of physiological responses across exposure frequency conditions
Changes in skin temperature, skin blood flow, thermal sensation scores, and stress biomarkers are compared among 28 GHz single exposure, 2 GHz single exposure, and combined exposure to both frequencies.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
28 GHz Single-Frequency Exposure : To evaluate the effects of single-frequency exposure to 28 GHz millimeter-wave radiation on human skin by assessing changes in skin surface temperature, skin blood flow, thermal sensation, and stress-related biomarkers.
Interventions/Control_2
2 GHz Single-Frequency Exposure : To evaluate the effects of single-frequency exposure to 2 GHz radiofrequency fields on human skin by assessing changes in skin surface temperature, skin blood flow, thermal sensation, and stress-related biomarkers.
Interventions/Control_3
Combined Exposure to 28 GHz and 2 GHz : To evaluate the physiological effects of simultaneous exposure to 28 GHz and 2 GHz radiofrequency fields and to compare these responses with those observed under single-frequency exposure conditions in order to identify effects specific to combined multi-frequency exposure.
Interventions/Control_4
Thermal Load (Positive Control: Heating Using a Heater, etc.) : To apply thermal stimulation to the dorsal skin using a heater (or equivalent device) and to assess changes in skin temperature, skin blood flow, thermal sensation, and stress-related biomarkers. This intervention serves as a comparator to examine whether responses observed during radiofrequency exposure can be explained by thermal effects.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Adults aged between 18 and 79 years at the time of obtaining informed consent.
2. Healthy individuals.
3. Individuals who have received sufficient explanation of the purpose and procedures of the study and have provided written informed consent.
4. Individuals who are able to undergo radiofrequency exposure, skin temperature measurement, skin blood flow measurement, and thermal sensation assessment as specified in the study protocol.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
1. Individuals with skin conditions at the measurement site (dorsal skin) that would make the planned measurements or assessments difficult to perform at the time of the study.
2. Individuals who are judged by the principal investigator or study investigators to be inappropriate for participation in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | MASUDA |
Organization
Kurume University
Division name
Department of Environmental Medicine, School of Medicine
Zip code
830-0011
Address
67 Asahimach, Kurume, Fukuoka, Japan
TEL
0942-31-7552
bdxmsdb@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | MASUDA |
Organization
Kurume University
Division name
Department of Environmental Medicine, School of Medicine
Zip code
830-0011
Address
67 Asahimach, Kurume, Fukuoka, Japan
TEL
0942-31-7552
Homepage URL
bdxmsdb@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications (MIC)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Medical Research, Kurume University
Address
67 Asahimach, Kurume, Fukuoka, Japan
Tel
0942-35-3311
i_rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069174
