UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063053 |
|---|---|
| Receipt number | R000072161 |
| Scientific Title | Clinical trial to evaluate the changes in epidermal condition after cleansing |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/24 14:39:51 |
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Basic information
Public title
Clinical trial to evaluate the changes in skin condition after cleansing
Acronym
Clinical trial to evaluate the changes in skin condition after cleansing
Scientific Title
Clinical trial to evaluate the changes in epidermal condition after cleansing
Scientific Title:Acronym
Clinical trial to evaluate the changes in epidermal condition after cleansing
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether cleansing changes the epidermal condition, and whether those changes vary depending on the type of cleanser
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of skin condition based on Raman spectra recorded using an in vivo confocal Raman spectrometer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Cleansing of the test sites a predetermined number of times using Cleanser A
Interventions/Control_2
Cleansing of the test sites a predetermined number of times using Cleanser B
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy male and female subjects aged 30 years or older and younger than 60 years
Key exclusion criteria
1) Subjects with severe atopic dermatitis.
2) Subjects receiving hormone therapy.
3) Subjects with a history of allergy to cosmetics or medications, or those with self-reported sensitive skin.
4) Subjects who are pregnant, may be pregnant, or are breastfeeding.
5) Subjects with severe cardiac, renal, or hepatic disease, suspected cardiovascular disease, or a history of any of these conditions.
6) Subjects who are currently undergoing, or have undergone within the previous 3 months, treatments that affect skin function on the volar forearm, including chemical peels, laser treatments, or physician-prescribed medications (e.g. hydroquinone, high-concentration vitamin C preparations, or retinoic acid).
7) Subjects currently participating in another clinical trial.
8) Subjects with extensive wounds, warts, and/or rashes on the volar forearm.
9) Subjects deemed unsuitable for participation in the trial by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nakatake |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3680
nakatake_ryouichi@fancl.co.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Mogami |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3694
Homepage URL
rie0504@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
FANCL Corporation Ethics Committee
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, 244-0806, Japan
Tel
045-820-3423
yaokuhara@fancl.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 | 09 | Month | 26 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072161
