UMIN-CTR Clinical Trial

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
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
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	Completed
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	2019 Year 06 Month 28 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 26 Day
Last modified on	2019 Year 07 Month 01 Day

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