UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059517 |
|---|---|
| Receipt number | R000068080 |
| Scientific Title | An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/23 14:58:51 |
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Basic information
Public title
An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older
Acronym
An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older
Scientific Title
An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older
Scientific Title:Acronym
An Efficacy Study of Minon Whole Body Moisturizing Milk in Elderly People Aged 75 Years and Older
Region
| Japan |
Condition
Condition
Xerosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of this drug based on the assessment of safety and degree of improvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy Evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply this drug to the lower legs twice daily (morning and evening) for 4 weeks.
Interventions/Control_2
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who express willingness to participate in the study, understand the explanation, and can provide written informed consent.
2. Japanese men and women aged 75 years or older.
3. Individuals who are aware of dryness of the skin on the lower legs.
4. Individuals who can visit Infoward Co., Ltd. Ebisu Skin Research Center (Shibuya-ku, Tokyo) without the need for special assistance or support.
5. Individuals who do not require special assistance or support for understanding informed consent, giving consent, and withdrawing consent (i.e., those who do not need a legal representative).
6. Individuals who are able to fill out documents such as consent forms, questionnaires, and usage diaries.
Key exclusion criteria
1. Individuals diagnosed with type 1 or type 2 diabetes.
2. Individuals diagnosed with malignant tumors.
3. Individuals diagnosed with skin diseases (such as atopic dermatitis, acne vulgaris, psoriasis, etc.).
4. Patients undergoing artificial dialysis.
5. Individuals diagnosed with liver diseases.
6. Individuals infected with infectious diseases (HBV/HCV/HIV/syphilis).
7. Individuals currently taking steroid preparations or immunosuppressants.
8. Individuals who have regularly used pharmaceuticals, quasi-drugs, cosmetics, etc. for moisturizing purposes on the lower legs within 4 weeks prior to the start of the study (temporary use is permitted).
9. Individuals who consume alcohol excessively.
10. Individuals currently participating or who have participated within the past 3 months in clinical trials, usage surveys, or product monitoring related to investigational drugs, cosmetics, pharmaceuticals, etc.
11. Individuals who have experienced severe allergic reactions in the past due to the use of topical medications, cosmetics, quasi-drugs, or other products.
12. Individuals employed by pharmaceutical manufacturers or cosmetics companies, including the subjects themselves or their family members.
13. Any other individuals deemed unsuitable by the study physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ito |
Organization
DAIICHI SANKYO HEALTHCARE CO., LTD.
Division name
Research Headquarters
Zip code
1038234
Address
3-14-10 Nihonbashi, Chuo-ku, Tokyo, JAPAN
TEL
03-5255-6222
shinji.ito@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Infoward Co., Ltd.
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
5th Floor, Sanke 51 Building, 1-11-2 Ebisu, Shibuya-ku, Tokyo, Japan
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
Infoward Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO HEALTHCARE 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
603, 2972-8 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
Tel
090-3547-6398
NotApplicable
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 | 10 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068080
