UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061128 |
|---|---|
| Receipt number | R000069916 |
| Scientific Title | Exploratory Study of Skin Condition Following Use of Test Cosmetics |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/03/30 13:34:56 |
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Basic information
Public title
Exploratory Study of Skin Condition Following Use of Test Cosmetics
Acronym
Exploratory Study of Skin Condition Following Use of Test Cosmetics
Scientific Title
Exploratory Study of Skin Condition Following Use of Test Cosmetics
Scientific Title:Acronym
Exploratory Study of Skin Condition Following Use of Test Cosmetics
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the test cosmetics for skin conditions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin conditions
1)VISIA's indicators
2)Trans epidermal water loss
3)Stratum corneum moisture content
4)Mexameter's score
Key secondary outcomes
Subject self-assessment
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the three test products (lotion, serum, and cream) twice daily after washing in the morning and evening. Continue this for up to 12 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 or older at the time of consent acquisition
2) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study.
Key exclusion criteria
Individuals
1) who used the products containing stem cell culture supernatant within 4 weeks.
2) at risk of developing allergies related to ingredients in this trial cosmetic or to cosmetics.
3) who are pregnant, breastfeeding, may be pregnant, or plan to become pregnant during the study.
4) in other clinical trial within 4 weeks.
5) considered unsuitable for the study by the principle investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Takahashi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science & Data Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
hsrpd@rohto.co.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Shidomi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science & Data Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
Homepage URL
hsrpd@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shin-Kawasaki Eve Clinic for Dermatology and Aesthetic Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
rinri@s-palace-clinic.com
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 | 04 | Month | 02 | 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 | 03 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069916
