UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052024 |
|---|---|
| Receipt number | R000059338 |
| Scientific Title | Efficacy of moisturizer in elderly women |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2023/08/28 14:01:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of moisturizer in elderly women
Acronym
Efficacy of moisturizer in elderly women
Scientific Title
Efficacy of moisturizer in elderly women
Scientific Title:Acronym
Efficacy of moisturizer in elderly women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of skin condition improvement and systemic inflammation suppression by using moisturizer in elderly women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of skin findings by a dermatologist
Water content of the stratum corneum
Transepidermal water loss
Questionnaires
Serum levels of inflammatory cytokines
Key secondary outcomes
Biochemical and immune serology examination of blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Moisturizer group
A test product (moisturizer) is applied at least twice a day for four weeks on the test area (the entire body below the neck).
Interventions/Control_2
Control group
No moisturizer is applied for four weeks on the test 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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Japanese females between 70 years to 90 years old
(2) Subjects who agreed to participate in this study in writing after receiving a sufficient explanation of the purpose and contents of this study
(3) Subjects who adhere to the instructions for use of the test product and are willing to use the test product during the study period
Key exclusion criteria
(1) Those with a history of severe illness or complications requiring treatments
(2) Those who are taking or using medications that may affect the study
(3) smoker
(4) Those who are likely to develop allergies to cosmetics and food (including those who have experienced skin abnormalities such as rashes due to cosmetics within the past year)
(5) Those who are currently participating in other clinical trials
(6) In addition, those who are judged to be inappropriate for participation in this study by the principal investigator
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Nakaoji |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
651-2241
Address
1-3-1, Murotani Nishi-ku, Kobe
TEL
078-992-6591
knakaoji@pias.co.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Iwai |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
651-2241
Address
1-3-1, Murotani Nishi-ku, Kobe
TEL
078-992-6591
Homepage URL
miwai@pias.co.jp
Sponsor or person
Institute
Pias Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hakodate Central General Hospital Medical Ethics Committee
Address
33-2, Honcho, Hakodate, Hokkaido, Japan
Tel
0138-52-1231
funaki-m@hakochu-hp.gr.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
| 2023 | Year | 08 | Month | 28 | 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
75
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
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059338
