UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057215 |
|---|---|
| Receipt number | R000065400 |
| Scientific Title | Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women. |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/03/05 16:20:37 |
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Basic information
Public title
Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women.
Acronym
Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women.
Scientific Title
Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women.
Scientific Title:Acronym
Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women.
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of single and combined use of Test Product 1 and Test Product 2 on the surface area of stratum corneum cells in healthy women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Surface of the stratum corneum
Key secondary outcomes
Skin hydration, Skin observation by doctor
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The test product, which is dispensed with two pushes, was applied topically twice a day for 8 weeks.
Interventions/Control_2
non-appplication area
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
- Healthy adult females between the ages of 50 and 80 years old.
- Subjects will be divided into three age groups (50-59, 60-69, and 70-79 years old), and the first 30 subjects in each group will be selected.
- Subjects with a larger average stratum corneum area measured from both the left and right hands, and with a difference of less than 15% between the two values, will be selected.
Key exclusion criteria
- Subjects with excessive sunburn on the test area at the time of consent.
- Subjects with wounds, warts, or skin conditions (such as urticaria, inflammation, eczema, trauma, acne, or pimples) on the test area at the time of consent.
- Subjects receiving treatment or preventive measures (such as hormone replacement therapy, pharmacotherapy, exercise therapy, dietary therapy, etc.) at medical institutions at the time of consent.
- Subjects who have been exposed to ultraviolet rays beyond daily life, such as long hours of outdoor work, exercise, swimming, or leisure activities, from one month before the time of consent.
- Subjects who have habitually applied or adhered makeup products, cosmetics, or quasi-drugs to the test area from one month before the time of consent.
- Subjects who have shaved, depilated, or removed hair from the test area from one month before the time of consent.
- Subjects who have received special skincare treatments (such as beauty salons or esthetic treatments) on the test area from one month before the time of consent.
- Subjects who have habitually washed the test area with hard materials like nylon products from one month before the time of consent.
- Subjects who have participated in other human trials (using cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, etc.) from one month before the time of consent.
- Subjects who have habitually applied or adhered medical pharmaceuticals to the test area from six months before the time of consent.
- Subjects who have previously received cosmetic medical treatments (such as Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the test area.
- Subjects with a history of hypersensitivity to cosmetics or other products, or those who may exhibit allergic symptoms.
- Subjects with a history or current condition of atopic dermatitis, or those judged by the principal investigator to have symptoms resembling atopic dermatitis.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Syota |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Skin Care Research Institute
Zip code
5200002
Address
3-31-13 Saigawa, Otsu, Shiga, Japan
TEL
0775218835
Shimizu.Syota@otsuka.jp
Public contact
Name of contact person
| 1st name | Syota |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Skin Care Research Institute
Zip code
5200002
Address
3-31-13 Saigawa, Otsu, Shiga, Japan
TEL
0775218835
Homepage URL
Shimizu.Syota@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
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
Brain Care Clinic Ethics Review Committee
Address
Shiratori Bldg. 2F, 2-1-2 Shinjuku, Shinjuku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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 | 09 | Month | 01 | 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
65
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 10 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065400
