UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044170 |
|---|---|
| Receipt number | R000050438 |
| Scientific Title | Safety evaluation for combined use of 4 cosmetic preparations |
| Date of disclosure of the study information | 2021/05/11 |
| Last modified on | 2021/08/31 09:11:25 |
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Basic information
Public title
Safety evaluation for combined use of 4 cosmetic preparations
Acronym
Safety evaluation for combined use of 4 cosmetic preparations
Scientific Title
Safety evaluation for combined use of 4 cosmetic preparations
Scientific Title:Acronym
Safety evaluation for combined use of 4 cosmetic preparations
Region
| Japan |
Condition
Condition
Healthy Japanese women between the ages of 30 and 59
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to confirm the safety of 4 test products after combined daily use for 8 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin findings(Medical examination) : 0-8 weeks
Adverse events : 0-8 weeks
Subjective symptoms(Questionnaire, life diary) : 8 weeks
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Continuous use every morning and evening for 8 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy Japanese women aged 30 to 59 at the time of screening test
2. A person who has received sufficient explanation about the test product as well as the purpose and content of this research, and then given written consent to participate in the research voluntarily.
Key exclusion criteria
1. Persons who have factors that affect the evaluation at the evaluation site including atopic dermatitis, trauma, burns, inflammation, acne, warts, etc.
2. Those who go to the hospital for treatment of an affected area on the face
3. Those who have a history of allergies to cosmetics
4. Those who are receiving hormone replacement therapy
5. Those who are pregnant or breastfeeding, or those who will not use proper birth control because of wishing to become pregnant during the period from the time of giving consent to the end of the study.
6. Those who have received cosmetic medicine that affects the evaluation site, or those who plan to receive it during the research period
7. Those who have undergone special skin care treatment (facial treatment, etc.) that affects the evaluation site within 4 weeks before the start of application of the test product, or those who are planning to receive it during the research period.
8. Those who received the test product in other clinical trials within 4 weeks before the start of application of the test product, or those who plan to participate in other trial during the research period
9. Those who are judged to be ineligible by the principal investigator or investigators with other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Center for Clinical Pharmacology
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Noevir Co., Ltd.
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
Medical corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel
011-881-0111
matsuda@ughp-cpc.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
| 2021 | Year | 05 | Month | 11 | 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
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 | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 03 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
