UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039938 |
|---|---|
| Receipt number | R000045487 |
| Scientific Title | Evaluation of the safety and efficacy of continuous use of skincare formulations |
| Date of disclosure of the study information | 2020/03/25 |
| Last modified on | 2020/09/24 08:34:59 |
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Basic information
Public title
Evaluation of the safety and efficacy of continuous use of skincare formulations
Acronym
Evaluation of the safety and efficacy of continuous use of skincare formulations
Scientific Title
Evaluation of the safety and efficacy of continuous use of skincare formulations
Scientific Title:Acronym
Evaluation of the safety and efficacy of continuous use of skincare formulations
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and efficacy of the
continuous use of moisturizing agents in subjects with facial dryness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Evaluation of improvement in cutaneous
findings and dryness/scaly skin
2) Frequency of adverse events
Key secondary outcomes
Instrumental measurements
1) Water content of stratum corneum
2) Transepidermal water loss
3) Pathological examination of the stratum corneum
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
The test product is applied to the entire face twice a day (morning and evening).
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
People who meet inclusion criteria 1) to 7) listed below and meet none of the exclusion criteria will be enrolled in the increasing order of the measured moisture content in the stratum corneum, with a target of 44 subjects with the lowest moisture content in the stratum corneum.
Inclusion criteria:
1) Subjects who were willing to participate in the study and, after receiving an explanation of the study, who provided voluntary consent to participate in the study.
2) Healthy Japanese women aged between 20 years and less than 60 years who meet none of the exclusion criteria
3) Subjects who can complete documents such as a consent form and journal form
4) Subjects who can provide responses to an Internet-based questionnaire
5) Subjects who can visit the designated facility on the day of measurement
6) Subjects who have slight-to-mild facial dryness and scaly skin on the face or have a history of atopic dermatitis, which is in remission at the time of screening, and have facial dryness.
7) Self-perception of having sensitive skin
Key exclusion criteria
1)Subjects who have a facial injury
2)Those who used a medicinal product that can potentially affect the study within 3 months of the start of the study or who will probably use a drug that can potentially affect the results during the study period
3)Subjects who underwent a cosmetic procedure such as collagen or hyaluronic acid injection, botox injection, chemical peeling, laser therapy, or phototherapy within 6 months of the start of the study or who will probably undergo one of the above-mentioned cosmetic procedures during the study period
4)Those currently receiving hormone replacement therapy or who will probably receive hormone replacement therapy during the study period
5)Those who will probably experience substantial exposure to sunlight during the study
6)Those who have previously developed serious skin problems arising from the use of cosmetic products or other similar products
7)Those who have previously developed
dermatitis due to adhesive tape or other similar products
8)Subjects whose face is affected by atopic dermatitis or another skin disease
9)Those who suffer from severe hay fever
10)Those who habitually consume excess amounts of alcohol
11)Those who are unable to discontinue drugs that can potentially affect the study results
12)Those who have a history of severe liver disease, kidney disease, myocardial infarction, or other similar serious conditions and who will probably start to receive a new treatment at a medical institution during the study period
13)Those who suffer from severe anemia
14)Those who are pregnant or will potentially become pregnant during the study or who are breast-feeding
15)Those who will have participated in another clinical study between 3 months before screening and the end of this study or will probably participate in another clinical study during this study period
16)Subjects whose enrollment in the study is considered inappropriate by the principal investigator
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Tsukamoto |
Organization
Beauty & Health Research Inc.
Division name
Clinical Research Division
Zip code
160-0023
Address
4th Floor, Sankyo Nishi-Shinjuku Bldg., 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5354-7388
info@b-hr.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Marume |
Organization
Beauty & Health Research Inc.
Division name
Clinical Research Division
Zip code
160-0023
Address
4th Floor, Sankyo Nishi-Shinjuku Bldg., 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5354-7388
Homepage URL
marume@b-hr.jp
Sponsor or person
Institute
Beauty & Health Research Inc.
Institute
Department
Personal name
Funding Source
Organization
KOSE Corporation
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
Hakuaikai G.K.
Address
3-10-2 Higashiazabu, Minato-ku, Tokyo
Tel
03-5354-7388
hakuaikai.rinri@gmail.com
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
株式会社ビューティアンドヘルスリサーチ
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 25 | 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
45
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
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045487
