UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063509 |
|---|---|
| Receipt number | R000072593 |
| Scientific Title | Evaluation of a Topical Formulation on Local Skin Stress Responses |
| Date of disclosure of the study information | 2026/11/04 |
| Last modified on | 2026/11/04 09:57:31 |
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Basic information
Public title
Evaluation of a Topical Formulation on Local Skin Stress Responses
Acronym
Evaluation on Local Skin Stress Responses
Scientific Title
Evaluation of a Topical Formulation on Local Skin Stress Responses
Scientific Title:Acronym
Evaluation on Local Skin Stress Responses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of topical formulation on skin inflammatory and stress responses induced by localized heat exposure in healthy adults using RNA sequencing of skin tissue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Within-participant comparison between topical formulation-treated and untreated forearm sites of changes from baseline in the expression of inflammation- and stress-response-related genes and gene sets.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Topical application of a formulation (Right arm)
Interventions/Control_2
Untreated (Left arm)
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Men aged 18-59 years at the time of informed consent.
2) No skin symptoms at either forearm test site that could affect evaluation.
3) Able to understand the study purpose and procedures and voluntarily provide written informed consent.
4) Able to attend scheduled visits and comply with study requirements.
5) Considered eligible by the principal investigator.
Key exclusion criteria
1) Skin disease, rash, wounds, severe sunburn, or similar conditions at the forearm test sites.
2) Special skin care procedures (e.g., beauty salon or aesthetic treatments) at the test sites within the past four weeks.
3) Habitual skin care of the forearm test sites.
4) Abnormal sensation to thermal stimuli.
5) Diseases or medication use that may affect wound healing.
6) Bleeding tendency or use of medication that may affect bleeding.
7) History of keloids or hypertrophic scars.
8) Allergic reactions to alcohol-based disinfection.
9) History of hypersensitivity or skin reactions to medical tape or adhesives.
10) Acute infection, fever, or marked poor health within the past week.
11) History of hypersensitivity to study product ingredients or cosmetics.
12) Participation in another clinical trial within the past month, current participation, or planned participation during this study.
Target sample size
10
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
0742718772
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
0742718772
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F, Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo, Japan
Tel
03-6240-1162
jimukyoku@tes-h.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
うえのあさがおクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 04 | 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 | 10 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 25 | 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 | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072593
