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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035370
Receipt No. R000039480
Scientific Title Application test of skin care cosmetic mediqol for sensitive skin
Date of disclosure of the study information 2019/01/05
Last modified on 2019/05/15

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Basic information
Public title Application test of skin care cosmetic mediqol for sensitive skin
Acronym Application test of skin care cosmetic mediqol for sensitive skin
Scientific Title Application test of skin care cosmetic mediqol for sensitive skin
Scientific Title:Acronym Application test of skin care cosmetic mediqol for sensitive skin
Region
Japan

Condition
Condition Moisture retention
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine skin condition when used skin care cosmetic mediqol for 4 weeks
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire survey and observation for skin condition by a doctor (Week 0, Week 2, Week 4)
Key secondary outcomes Transepidermal water loss, skin moisture/oiliness content, erythema, picture evaluation (Week 0, Week 2, Week 4)

As other indexes : safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Using cosmetic twice a day for 4 consecutive weeks
Interventions/Control_2
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)Individuals who require moisture retention judged by a doctor
2)Individuals who can visit to clinic (Japanese males or females)
3)Individuals providing written informed consent
4)Individuals not younger than 20 years old at the time of informed consent
Key exclusion criteria 1)Individuals who are sensitive to test product
2)Individuals who are or are possibly pregnant, or are lactating
3)Individuals with severe skin diseases
4)Individuals without capacity to consent
5)Individuals judged inappropriate for the study by a doctor
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name Yuko
Middle name
Last name Nomura
Organization Medical Corporation Soyokazekai, Nomura Dermatology Clinic
Division name Director
Zip code 221-0825
Address 4-27-14 Tanmachi, Kanagawa-ku, Yokohama, Kanagawa
TEL 045-328-1377
Email nomunomuhifuka@hotmail.com

Public contact
1st name of contact person
1st name Yoko
Middle name
Last name Yamaguchi
Organization Nanoegg Research Laboratories, Inc.
Division name Pharmaceutical Products Research and Development Section
Zip code 210-0821
Address Innovation Center of NanoMedicine 4F, 3-25-14 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL 044-400-1155
Homepage URL
Email rdm@nanoegg.co.jp

Sponsor
Institute Nanoegg Research Laboratories, Inc.
Institute
Department

Funding Source
Organization Nanoegg Research Laboratories, Inc.
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 IRB
Address 3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel 03-5543-0196
Email kaneko@smo-msr.co.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 01 Month 05 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 20
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
2018 Year 11 Month 14 Day
Date of IRB
2018 Year 12 Month 17 Day
Anticipated trial start date
2019 Year 01 Month 25 Day
Last follow-up date
2019 Year 04 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 26 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039480

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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