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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039426
Receipt No. 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 2020/02/07

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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
Email 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
Email jyotsuya@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 07 Day
Last modified on
2020 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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