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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044170
Receipt No. 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

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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
Email 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
Email matsuda@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050438

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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