UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analyses of the skin molecules in healthy males.
Title of the study (Brief title)	Analyses of the skin molecules in healthy males.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the skin molecules in healthy males.
Basic objectives2	Others
Basic objectives -Others	The observational study of the skin molecules in healthy males.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The composition of the skin molecules in healthy males.
Key secondary outcomes	The relationship between skin molecules and questionnaires.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	56 years-old >=
Gender	Male
Key inclusion criteria	1.Healthy male panelists who are 40-59 years old. 2.Panelists who agree to have their typical daily routines.
Key exclusion criteria	1.Panelists who have the skin problems on the face, such as atopic dermatitis, psoriasis vulgaris, and acnes. 2.Panelists who have a severe tanning on the face 3.Panelists who have habits of outdoor activities causing a severe tanning. 4.Panelists who use the drug such as, anti-inflammatory drug, antibiotics, hypnotic, anti- allergic drug, analgesic drug, hormone preparation, laxative, intestinal regulator, and other drugs as routinely. 5.Panelists who attend for treatment of chronic diseases (e.g. stomach, intestine, kidney, heart, blood pressure, skin, and other illness) or have history of attending within a month before participation in this study (Manual therapy, chiropractic, massages, and osteopathic manipulation are exceptional). 6.Panelists who attend cosmetic therapy (e.g. chemical peeling, laser therapy) or have history of cosmetic surgery (e.g. cosmetic orthopedics, collagen injection). 7.Panelists who have participated or scheduled in other study during the period of this study. 8.Panelists who is considered as inappropriate in this study. 9.prescription topical agents on the face
Target sample size	100

Research contact person
Name of lead principal investigator	Takayoshi Inoue
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7498
Email	inoue.takayoshi@kao.com

Public contact
Name of contact person	Yuya Uehara
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7461
Homepage URL
Email	uehara.yuuya@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo University
Name of secondary funｄer(s)

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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 06 Month 20 Day
Anticipated trial start date	2018 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The observational study of the skin molecules in healthy males.

Management information
Registered date	2018 Year 06 Month 14 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037611