UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039426 |
|---|---|
| Receipt number | R000044904 |
| Scientific Title | Investigation of effective moisturizer for older people dry skin |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2020/06/03 16:11:45 |
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Basic information
Public title
Investigation of effective moisturizer for older people dry skin
Acronym
Effective moisturizer for older people dry skin
Scientific Title
Investigation of effective moisturizer for older people dry skin
Scientific Title:Acronym
Effective moisturizer for older people dry skin
Region
| Japan |
Condition
Condition
Dry skin
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of three moisturizers on older people dry skin using physiological and morphogical evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in water content at stratum corneum at 8 weeks after the start of the survey
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply a moisturizer No.1 twice a day for 8 weeks
Interventions/Control_2
Apply a moisturizer No.2 twice a day for 8 weeks
Interventions/Control_3
Apply a moisturizer No.3 twice a day for 8 weeks
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons with dry skin on lower legs
Persons who have been given sufficient explanations to participate in this study and have given their full understanding and consent to their own free will.
Key exclusion criteria
Persons who are being treated for skin diseases
Persons with wound on lower leg
Persons with allergies or hypersensitivity to cosmetics
Persons with severe condition
Persons who are judged to be inappropriate as a research subject by investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Yotsuya |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
9101193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
jyotsuya@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Yotsuya |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences
Zip code
9101193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
Homepage URL
jyotsuya@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Coloplast
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 Research Support Center
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-8529
chiken@ml.u-fukui.ac.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
| 2020 | Year | 02 | Month | 07 | 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
23
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 07 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044904
