UMIN-CTR Clinical Trial

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