UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary study test to confirm the effect of new cosmetics on the skin .
Acronym	Preliminary study test to confirm the effect of new cosmetics on the skin .
Scientific Title	Preliminary study test to confirm the effect of new cosmetics on the skin .
Scientific Title:Acronym	Preliminary study test to confirm the effect of new cosmetics on the skin .
Region	Japan

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

Objectives
Narrative objectives1	Evaluate changes in skin condition when healthy adult female use cosmetics cream for 4 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of skin condition before starting use of test article and 4 weeks after use
Key secondary outcomes

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 essence 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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	"1.Healthy person without serious illness. 2.Women who have wrinkles and stains on the face. 3.Those aged 40 to 65 who can voluntarily participate in clinical trials and obtain written consent. 4.Those who have not changed basic cosmetics within 1 month before the start of the test. 5.Those who can use basic cosmetics only for test products during the test period. 6.Those who have not regularly ingested health foods that may have an effect on the skin within one month before the start of the test. 7.Those who do not receive special skin care treatment from 1 month before the start of the test during the test period, and who can avoid exposure to ultraviolet rays such as swimming, mountain climbing, sunbathing, outdoor exercise, etc. 8.Those who can maintain a constant daily lifestyle during the test period. 9.Those who are treating mild chronic diseases (hypertension, hyperlipidemia, etc.) may participate in the study at the discretion of the investigator."
Key exclusion criteria	"1.Those with serious illness (heart disease, liver disease, kidney disease, cancer, etc.) or mental illness. 2.Those who regularly take internal or external medicines within 1 month of the start of the test due to skin diseases such as atopic dermatitis and urticaria, or who take 1/3 or more of the month. 3.Those with skin disorders that may affect the test. 4.Those who have experienced allergic symptoms with cosmetics containing placenta, those who are allergic to drugs. 5.Pregnant / lactating women and those who wish to become pregnant during the test period. 6.Subjects who are judged as unsuitable for the study by the investigator for the other reason. 7.Those who have participated in other clinical trials within the past month."
Target sample size	15

Research contact person
Name of lead principal investigator	1st name kimie Middle name Last name ito
Organization	Nihonbashi Sakura Clinic
Division name	Director
Zip code	103-0025
Address	1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japan
TEL	03-6661-9061
Email	mail-1@ouryokukai.sakura.ne.jp

Public contact
Name of contact person	1st name tatsuo Middle name Last name uetake
Organization	CXwellness, Inc.
Division name	Representative Director
Zip code	103-0023
Address	516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo,Japan.
TEL	03-6225-5601
Homepage URL
Email	uetake@cx-wellness.com

Sponsor
Institute	Nihonbashi Sakura Clinic
Institute
Department

Funding Source
Organization	Universal Transcend Planning, 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	uenoasagaorinrisinsaiinkai
Address	2-7-5,Higashiueno,Taito-ku,Tokyo,Japan
Tel	03-6240-1162
Email	info@ueno-asagao.clinic

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	日本橋さくらクリニック

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	13
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	2021 Year 06 Month 20 Day
Date of IRB	2021 Year 06 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 03 Day
Last follow-up date	2021 Year 07 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	2021 Year 09 Month 01 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051052