UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043597 |
|---|---|
| Receipt number | R000049696 |
| Scientific Title | Evaluation of correlation between vital data, environmental data and skin condition, and improvement effect of cosmetic application |
| Date of disclosure of the study information | 2021/03/12 |
| Last modified on | 2021/07/02 11:23:40 |
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Basic information
Public title
Evaluation of correlation between vital data, environmental data and skin condition, and improvement effect of cosmetic application
Acronym
Evaluation of correlation between vital data, environmental data and skin condition, and improvement effect of cosmetic application
Scientific Title
Evaluation of correlation between vital data, environmental data and skin condition, and improvement effect of cosmetic application
Scientific Title:Acronym
Evaluation of correlation between vital data, environmental data and skin condition, and improvement effect of cosmetic application
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between vital data, environmental data and skin condition. And to evaluate the improvement effect of cosmetic application
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum moisture content
Key secondary outcomes
Transepidermal water loss (0w, 4w, 8w)
Skin image analysis
Heart rate, Heart rate variability, Body surface temperature
Environmental sensor
Questionnaire
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
Apply the skin lotion and emulsion on facial skin for 4 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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy Japanese women who are between 30 and 49 years old
2. Subjects who are concerned about dryness, transparency, and dullness of the facial skin
3. Subjects who can give written informed consent of their own free will before this study
Key exclusion criteria
1. Subjects with chronic skin conditions such as atopic dermatitis, or significant skin abnormalities of the face
2. Subjects with allergic symptoms or peculiar constitution to drugs or cosmetics
3. Subjects with current or history of cerebral nervous system disease, heart disease, psychiatric disease, or sleep-related disease
4. Subjects who are undergoing hormone replacement therapy for menopausal disorders or who have not been treated for at least 6 months
5. Pregnant or lactating women, or those who plan to become pregnant during the study period
6. Subjects who are participating in other clinical trials
7. Subjects who are judged ineligible by the study physician or the study director
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Takahashi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Skin Care Product Development Division
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
TEL
06-6758-1231
kyokotak@rohto.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Inaoka |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Skin Care Product Development Division
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
TEL
06-6758-1231
Homepage URL
inaoka@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YOKO CLINIC Ethics Review Committee
Address
188-14, Ishikawa-cho, Hakodate, Hokkaido
Tel
0138-47-4059
funaki-m@omist.co.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 | 03 | Month | 12 | 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 | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 07 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049696
