UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the safety and efficacy of continuous use of skincare formulations
Acronym	Evaluation of the safety and efficacy of continuous use of skincare formulations
Scientific Title	Evaluation of the safety and efficacy of continuous use of skincare formulations
Scientific Title:Acronym	Evaluation of the safety and efficacy of continuous use of skincare formulations
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and efficacy of the continuous use of moisturizing agents in subjects with facial dryness
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Evaluation of improvement in cutaneous findings and dryness/scaly skin 2) Frequency of adverse events
Key secondary outcomes	Instrumental measurements 1) Water content of stratum corneum 2) Transepidermal water loss 3) Pathological examination of the stratum corneum

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	The test product is applied to the entire face twice a day (morning and evening).
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	60 years-old >
Gender	Female
Key inclusion criteria	People who meet inclusion criteria 1) to 7) listed below and meet none of the exclusion criteria will be enrolled in the increasing order of the measured moisture content in the stratum corneum, with a target of 44 subjects with the lowest moisture content in the stratum corneum. Inclusion criteria: 1) Subjects who were willing to participate in the study and, after receiving an explanation of the study, who provided voluntary consent to participate in the study. 2) Healthy Japanese women aged between 20 years and less than 60 years who meet none of the exclusion criteria 3) Subjects who can complete documents such as a consent form and journal form 4) Subjects who can provide responses to an Internet-based questionnaire 5) Subjects who can visit the designated facility on the day of measurement 6) Subjects who have slight-to-mild facial dryness and scaly skin on the face or have a history of atopic dermatitis, which is in remission at the time of screening, and have facial dryness. 7) Self-perception of having sensitive skin
Key exclusion criteria	1)Subjects who have a facial injury 2)Those who used a medicinal product that can potentially affect the study within 3 months of the start of the study or who will probably use a drug that can potentially affect the results during the study period 3)Subjects who underwent a cosmetic procedure such as collagen or hyaluronic acid injection, botox injection, chemical peeling, laser therapy, or phototherapy within 6 months of the start of the study or who will probably undergo one of the above-mentioned cosmetic procedures during the study period 4)Those currently receiving hormone replacement therapy or who will probably receive hormone replacement therapy during the study period 5)Those who will probably experience substantial exposure to sunlight during the study 6)Those who have previously developed serious skin problems arising from the use of cosmetic products or other similar products 7)Those who have previously developed dermatitis due to adhesive tape or other similar products 8)Subjects whose face is affected by atopic dermatitis or another skin disease 9)Those who suffer from severe hay fever 10)Those who habitually consume excess amounts of alcohol 11)Those who are unable to discontinue drugs that can potentially affect the study results 12)Those who have a history of severe liver disease, kidney disease, myocardial infarction, or other similar serious conditions and who will probably start to receive a new treatment at a medical institution during the study period 13)Those who suffer from severe anemia 14)Those who are pregnant or will potentially become pregnant during the study or who are breast-feeding 15)Those who will have participated in another clinical study between 3 months before screening and the end of this study or will probably participate in another clinical study during this study period 16)Subjects whose enrollment in the study is considered inappropriate by the principal investigator
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Tsukamoto
Organization	Beauty & Health Research Inc.
Division name	Clinical Research Division
Zip code	160-0023
Address	4th Floor, Sankyo Nishi-Shinjuku Bldg., 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5354-7388
Email	info@b-hr.jp

Public contact
Name of contact person	1st name Ai Middle name Last name Marume
Organization	Beauty & Health Research Inc.
Division name	Clinical Research Division
Zip code	160-0023
Address	4th Floor, Sankyo Nishi-Shinjuku Bldg., 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5354-7388
Homepage URL
Email	marume@b-hr.jp

Sponsor
Institute	Beauty & Health Research Inc.
Institute
Department

Funding Source
Organization	KOSE Corporation
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	Hakuaikai G.K.
Address	3-10-2 Higashiazabu, Minato-ku, Tokyo
Tel	03-5354-7388
Email	hakuaikai.rinri@gmail.com

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	株式会社ビューティアンドヘルスリサーチ

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 25 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	45
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	2019 Year 11 Month 10 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2020 Year 01 Month 10 Day
Last follow-up date	2020 Year 04 Month 27 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 03 Month 25 Day
Last modified on	2020 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045487