UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061084 |
|---|---|
| Receipt number | R000069888 |
| Scientific Title | The Effects of Continuous Use of Three Cosmetic Products on Skin with Mild Atopic Dermatitis Symptoms: single blinded study |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 15:04:15 |
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Basic information
Public title
The Effects of Continuous Use of Three Cosmetic Products on Skin with Mild Atopic Dermatitis Symptoms
Acronym
RA study
Scientific Title
The Effects of Continuous Use of Three Cosmetic Products on Skin with Mild Atopic Dermatitis Symptoms: single blinded study
Scientific Title:Acronym
The Effects of Continuous Use of Three Cosmetic Products on Skin with Mild Atopic Dermatitis Symptoms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of continued use of the test articles on skin with mild atopic dermatitis symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POEM, VAS
Both before the start and 4 weeks later
Key secondary outcomes
Subjective Assessment
4 weeks later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
The test articles were used for 4 weeks on only one side of the face and one side of the arm (three articles on the face-soap, lotion, and serum-and only the serum on the arm)
Interventions/Control_2
Leave the other side of the face and the other side of the arm untreated
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects diagnosed with atopic dermatitis or with a history of the condition
2.Subjects with a POEM score of 5-9 for the face and arms
3.Subjects whose symptoms have remained relatively stable over the past month and who have not started any new treatments or changed their current treatment regimen
Key exclusion criteria
1.Individuals with excessive exudate, or those with extensive severe inflammation, bleeding, or excoriations
2.Individuals who have regularly used topical steroids, topical immunomodulators, or tacrolimus ointment within the past 2 weeks; individuals who have used oral steroids or immunosuppressants within the past 4 weeks; or individuals who have used biologics within the past 6 months
3.Individuals with skin conditions other than contact dermatitis, psoriasis, or atopic dermatitis on the study sites
4.Individuals who have undergone cosmetic medical procedures on the study sites
5.Pregnant or breastfeeding women, or women planning to become pregnant
6.Individuals undergoing hormone replacement therapy
7.Individuals with severe liver or kidney disease
8.Individuals who have undergone phototherapy within the past month
9.Individuals with an allergy to any component of the test product
10.Individuals who have participated in a human clinical trial within the past month, or who plan to do so during the study period
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
RISOU Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
C-TECJAPAN Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
m
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 | 03 | Month | 27 | 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 | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 04 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069888
