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
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
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
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
