UMIN-CTR Clinical Trial

Basic information
Public title	A study for the short-term application of topical product CG_01.
Acronym	A study for the short-term application of topical product CG_01.
Scientific Title	A study for the short-term application of topical product CG_01.
Scientific Title:Acronym	A study for the short-term application of topical product CG_01.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the topical agent on components of the skin and its relevance to skin conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The dryness score of the skin before and after application.
Key secondary outcomes	The skin hydration, pH, the image analysis of the skin surface, the analysis of components of the skin, the analysis of the questionnaire before and after application.

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	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the active agent to the one side of the cheek and the placebo to other side of the cheek twice a day for 8 days.
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	25 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	1. Healthy males aged from 25 to 50 years old. 2. Subjects with a high dryness score and a low skin hydration of the cheek selected by screening test. 3. Subjects who can agree to participate in the study and provide written informed consent.
Key exclusion criteria	1. Subjects with atopic dermatitis, contact dermatitis and cutaneous hypersensitivity 2. Subjects with problems in the skin of the face, such as wound, eczema, sunburn. 3. Subjects who is using topical agent on the skin of the face. 4. Subjects who attend a hospital or who take drugs. 5. Subjects with any allergies. 6. Subjects who is undergoing, or have received, medical cosmetic treatment such as chemical peeling, cosmetic surgery. 7. Smoker. 8. Subjects who is participating in, or have participated in, other clinical study. 9. Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinobu Mori
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7460
Email	mori.shinobu@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Satoko Fukagawa
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7579
Homepage URL
Email	fukagawa.satoko@kao.co.jp

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 09 Month 27 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	2017 Year 09 Month 20 Day
Date of IRB	2017 Year 09 Month 20 Day
Anticipated trial start date	2017 Year 09 Month 27 Day
Last follow-up date	2017 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 27 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033343