UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045340
Receipt number R000051052
Scientific Title Preliminary study test to confirm the effect of new cosmetics on the skin .
Date of disclosure of the study information 2021/09/01
Last modified on 2021/09/01 16:39:14

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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 or person

Institute

Nihonbashi Sakura Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name