UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062515 |
|---|---|
| Receipt number | R000071552 |
| Scientific Title | An Exploratory Study on the Effects of Human Sweat on the Skin |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/07 11:49:57 |
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Basic information
Public title
Study on the Effects of Human Sweat on the Skin
Acronym
Sweat & Skin Study
Scientific Title
An Exploratory Study on the Effects of Human Sweat on the Skin
Scientific Title:Acronym
SWEAT Study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of sweat on the skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will enter a controlled environmental chamber. Sweating will be induced by stepping in place at a rhythm.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Healthy adults aged 18 years or older and younger than 65 years at the time of informed consent.
-Individuals who experience sufficient sweating during summer or under hot and humid conditions.
-Individuals who have received an adequate explanation of the purpose and procedures of the study, have the capacity to provide consent, fully understand the study, voluntarily agree to participate, and provide written informed consent.
Key exclusion criteria
-Individuals who are currently receiving, or have received within the past month, pharmacological treatment for any disease, except for occasional medication for conditions such as headache or common cold.
-Individuals with a current or past history of psychiatric disorders, sleep disorders, hypertension, diabetes mellitus, dyslipidemia, or other serious diseases.
-Individuals with a current or past history of serious hepatic, renal, cardiac, pulmonary, hematological, or other disorders.
-Individuals who have previously sought medical attention or received treatment for heatstroke or suspected heatstroke.
-Individuals who currently have, or have had within the past month, a disease that may affect sweating, thermoregulation, hemodynamics, fluid/electrolyte balance, or level of consciousness, or who are receiving pharmacological treatment for such a condition.
-Individuals who have experienced fever, diarrhea, vomiting, severe fatigue, inadequate food intake, inadequate fluid intake, heatstroke-like symptoms, or symptoms suggestive of infection within one week prior to the study visit.
-Individuals who are pregnant or breastfeeding at the time of informed consent, or who wish to become pregnant during the study period.
-Individuals who have participated in another human study involving cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, or other interventions within the previous four weeks, or who plan to participate in another human study during the scheduled study period.
-Individuals with bleeding wounds, infectious skin diseases, severe acne, or other facial conditions considered likely to affect the quality or safety of sweat samples.
-Individuals otherwise considered unsuitable for participation by the principal investigator physician or sub-investigator physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kazutake |
| Middle name | |
| Last name | Fukada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Basic Research and Development Division
Zip code
619-0216
Address
6-5-4, Kunimidai, Kizugawa, Kyoto
TEL
0774-71-8770
fukada@rohto.co.jp
Public contact
Name of contact person
| 1st name | Kazutake |
| Middle name | |
| Last name | Fukada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Basic Research and Development Division
Zip code
619-0216
Address
6-5-4, Kunimidai, Kizugawa, Kyoto
TEL
0774-71-8770
Homepage URL
fukada@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-4405-1899
yuyosei@drc-web.co.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 | 08 | Month | 07 | 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
| 2026 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 24 | 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 | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071552
