UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062623 |
|---|---|
| Receipt number | R000071683 |
| Scientific Title | Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/19 18:48:00 |
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Basic information
Public title
Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis
Acronym
Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis
Scientific Title
Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis
Scientific Title:Acronym
Study to Evaluate the Moisturizing Effects of Continuous Use of the Test Product on Non-Lesional Skin in Subjects with Atopic Dermatitis
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the moisturizing effect of the continuous use of two ceramide-like compounds -containing lotions for three weeks in individuals with atopic dermatitis who exhibit dryness on the inner surfaces of both forearms.
Basic objectives2
Others
Basic objectives -Others
Efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin observation by a dermatologist
Stratum corneum moisture content (Skicon-200EX)
Transepidermal water loss (Tewameter TM HEX)
Skin texture (roughness/smoothness) and scaling
Key secondary outcomes
Collection of stratum corneum
Questionnaire regarding the usage log, product feel, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply the test product daily for 3 weeks.
Interventions/Control_2
Apply the product daily for three weeks.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Those who meet all of the following conditions will be selected.
1)Women aged 20 to under 60
2)Individuals with mild symptoms of atopic dermatitis*1
3)Individuals exhibiting dryness on the inner surfaces of both forearms.
4)Those who have expressed their willingness to participate in the study, understood the explanation, and can provide written consent to participate in the study.
*1: Based on the "Criteria for Atopic Dermatitis Severity" in the Japanese Dermatological Association's *Clinical Practice Guidelines for Atopic Dermatitis 2024*.
Key exclusion criteria
Those who meet any of the following criteria will be excluded.
1) Individuals with atopic dermatitis of moderate severity or worse (severity grade 1 or higher)
2) Individuals taking oral steroids, antihistamines, anti-allergy medications, immunosuppressants, or tranquilizers.
3) Individuals who have previously experienced severe allergic symptoms due to the use of topical preparations, cosmetics, quasi-drugs, or other products.
4) Individuals with a serious illness who are considered unsuitable for enrollment.
5) Individuals currently undergoing treatment or attending medical appointments for a medical condition (excluding the common cold or dental care).
6) Individuals who have a family member working for a pharmaceutical or cosmetics company.
7) Individuals participating in other studies involving clinical trials, cosmetics, quasi-drugs, or foods, or those who have participated in a clinical trial within the past four weeks.
8) Others who have been determined ineligible by investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
Inforward, inc
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
info@inforward.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Numano |
Organization
Inforward, inc
Division name
EBISU skin research center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
Homepage URL
info@inforward.co.jp
Sponsor or person
Institute
Inforward, inc
Institute
Department
Personal name
Funding Source
Organization
LIKES BEAUTY 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
General Incorporated Association Clinical Research Review Center
Address
2972-8-603, Ishikawamachi, Hachioji-chi, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 19 | 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 | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071683
