UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055729 |
|---|---|
| Receipt number | R000063680 |
| Scientific Title | Verification test of the effect of continuous use of the test product on skin condition |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2025/04/25 09:46:53 |
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Basic information
Public title
Verification test of the effect of continuous use of the test product on skin condition
Acronym
Verification test of the effect of continuous use of the test product on skin condition
Scientific Title
Verification test of the effect of continuous use of the test product on skin condition
Scientific Title:Acronym
Verification test of the effect of continuous use of the test product on skin condition
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of the test product (cream) on the skin condition of Japanese women between the ages of 20 and 65 after 6 weeks of continuous use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water content
Key secondary outcomes
Transepidermal water loss, Texture, Skin viscoelasticity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Test product 1 applies to the designated area for 6 weeks
Interventions/Control_2
Test product 2 applies to the designated area for 6 weeks
Interventions/Control_3
Test product 3 applies to the designated area for 6 weeks
Interventions/Control_4
Control product applies to the designated area for 6 weeks
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1.Japanese women between the ages of 20 and 65 at the time of obtaining written consent.
2.Subject who is aware of their skin dryness.
3.Subject who is able to strictly follow the instructions for use of the study products during the study period.
4.Subject who has been fully informed of the purpose and content of the study, is capable of consenting, understands the study well, voluntarily volunteers to participate in the study, and agrees to participate in the study in writing.
Key exclusion criteria
1.Subject who has skin diseases (atopic dermatitis, contact dermatitis, etc.), traumatic injuries, or subjective symptoms such as pain that may affect the examination.
2.Subject who is attending a dermatological clinic at the time of consent.
3.Subject who has a serious disease or disorder that would make participation in the study a risk to the subject.
4.Subject with a history of hypersensitivity to cosmetics.
5.Subject is using or will use during the study period any drugs, health foods or supplements that are known to affect the study.
6.Subject is receiving hormone replacement therapy.
7.Subject who has a history of cosmetic therapy that may affect the study site.
8.Subject who has used cosmetic devices or cosmetic appliances within 1 month of obtaining consent.
9.Subject who has participated in another clinical trial (research) within 1 month of obtaining consent or who plans to participate in another clinical trial (research) during the study period.
10.Subject who is currently pregnant or lactating, or who may become pregnant or lactating during the study period.
11.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takayasu |
| Middle name | |
| Last name | Noguchi |
Organization
Wakamoto Pharmaceutical Co.,LTD.
Division name
Healthcare Labotarory
Zip code
258-0018
Address
378 Kanade, Ohi-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
0465-83-8046
t.noguchi@wakamoto-pharm.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
530-0001
Address
Pacific Marks Nishi Umeda 4F, 2-6-20, Umeda, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
Wakamoto 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
Medical Corporation Taifukukai Osaka Nishi-Umeda Clinic Clinical Research Ethics Review Board
Address
Hotel Monterey Osaka (Maruito Nishi-Umeda Building) office floor 3F 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
n-irb@ml.taifukukai.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
| 2024 | Year | 10 | Month | 08 | 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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063680
