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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043597
Receipt No. 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

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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
Email 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
Email inaoka@rohto.co.jp

Sponsor
Institute ROHTO Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049696

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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