UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056793 |
|---|---|
| Receipt number | R000064915 |
| Scientific Title | Effects of the topical application of test product on skin condition: split-face, vehicle-controlled trial |
| Date of disclosure of the study information | 2025/01/23 |
| Last modified on | 2025/01/23 13:51:58 |
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Basic information
Public title
Effects of the topical application of test product on skin condition: split-face, vehicle-controlled trial
Acronym
Effects of the topical application of test product on skin condition
Scientific Title
Effects of the topical application of test product on skin condition: split-face, vehicle-controlled trial
Scientific Title:Acronym
Effects of the topical application of test product on skin condition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the test product on the skin environment and skin function when applied on the skin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin microbe composition
Key secondary outcomes
Skin function
Skin questionnaire
Skin image evaluation
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Topically apply the test product on the designated skin region for 2 weeks.
Interventions/Control_2
Topically apply the placebo on the designated skin region for 2 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults who are aged between 18 and 65 years at the time of informed consent.
2.Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.
Key exclusion criteria
Subjects --
1.who are judged by the principal investigator to be ineligible to participate in this study with regard to their health condition.
2.with current or history of serious illnesses, especially those with complications or history of skin disease.
3.judged by the principal investigator to be unsuitable for this study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
aabe@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Morishima |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
Homepage URL
smorishima@taiyokagaku.co.jp
Sponsor or person
Institute
Taiyo Kagaku Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Taiyo Kagaku Co., Ltd institutional review board
Address
1-3 Takaramachi, Yokkaichishi, Mie
Tel
059-347-5400
jfunabashi@taiyokagaku.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
| 2025 | Year | 01 | Month | 23 | 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
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064915
