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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036266
Receipt No. R000041298
Scientific Title Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Date of disclosure of the study information 2019/04/01
Last modified on 2020/10/09

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Basic information
Public title Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Acronym Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Scientific Title Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Scientific Title:Acronym Clinical study of moisturizer on skin physiologic action for asteatosis cutis.
Region
Japan

Condition
Condition Asteatosis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Bioequivalence assessment of heparinoid-containing moisturizer versus reference petrolatum based on skin surface hydration, sebum and disease severity.
Basic objectives2 Others
Basic objectives -Others Bioequivalence assessment based on skin surface hydration, sebum and disease severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of sebum after application for 2 weeks
Key secondary outcomes Skin surface hydration, severity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Moisturizer
Interventions/Control_2 14 days
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Person older than 20years. 2 .Person who agree to participate in this trial. 3 Person with asteatosis.
Key exclusion criteria 1.Patient with iching due to other than dry skin.
2.Patient with skin ulcer or erosion at the site.
3.Person who has hypersensitivity for moisturizer and base.
4 Person who enrolled in other cclinical trial within a month.
5 Person who was disqualified by prin cipal clinician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yumi
Middle name
Last name Aoyama
Organization Kawasaki Medical School
Division name Dermatology
Zip code 701-0192
Address 577, Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Email ymaoyama@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Yumi
Middle name
Last name Aoyama
Organization Kawasaki Medical School
Division name Dermatology
Zip code 700-0192
Address 577, Matsushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email ymaoyama@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yakage Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization abc
Address 577, Matsushima, Kurashiki, Okayama, Japan
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.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
2019 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 31 Day
Date of IRB
2019 Year 04 Month 12 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2022 Year 03 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
2019 Year 03 Month 20 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041298

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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