UMIN-CTR Clinical Trial

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