UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of Skin Lotion on Drying of Skin (A Four Week Trial)
Title of the study (Brief title)	The Effect of Skin Lotion on Drying of Skin
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the effect of 4-week usage of the test product on the skin condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Skin moisture content (preliminary observation, Week 4) [2]Transepidermal water loss (preliminary observation, Week 4)
Key secondary outcomes	[1]Sebum capacity (preliminary observation, Week 4) [2]Skin pH (preliminary observation, Week 4) [3]Visual evaluation by a medical specialist/ physician's interview (preliminary observation, Week 4) [4]Horny layer analysis(preliminary observation, Week 4) [5]Subjective questionnaire (preliminary observation, Week 4) [6]Subject's diary (From the first day of using a test material to the last day of the test)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Applying a test product A (on the left-half of the face; 1ml/day [twice a day]; 4 weeks)
Interventions/Control_2	Applying a test product B (on the right-half of the face; 1ml/day [twice a day]; 4 weeks)
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	50 years-old >
Gender	Female
Key inclusion criteria	[1]Japanese males and females aged 30-49 years [2]Individuals who are healthy and have no chronic physical disease including skin disease [3]Individuals who are worry about drying of skin [4]Individuals who apply basic skin-care products with a way of the following patterns a)unused b)only lotion c)lotion + milky liquid d)lotion + beauty liquid [5]Individuals who can change a lotion being used to a test product [6]Individuals whose written informed consent has been obtained [7]Individuals who can have an examination in a designated day [8]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals with skin disease, such as atopic dermatitis [3]Individuals with strange skin conditions at measurement points [4]Individuals who used or applied a drug for treatment of disease in the past 1 month [5]Individuals who changed or will change skin care products during the test period in the past 2 months [6]Individuals who have a history of applying steroidal anti-inflammatory agent for treatment of skin disease in the past 6 months [7]Individuals who are sensitive to cosmetics [8]Individuals who would emerge seasonal allergy and use drugs (except eye drops and nose drops) [9]Individuals who used cosmetics or drugs improving skin moisture or tension at measurement points in the past 3 months [10]Individuals who treated or will treat cosmetics or drugs claiming chemical peeling on measurement points in the past 3 months [11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period [12]Individuals who cannot avoid daylight exposure during the test period [13]Individuals who had an operation at measurement point in the past 6 months [14]Individuals who have an addiction to alcohol or a mental illness [15]Individuals whose life style will change during the test period [16]Individuals who participate or will participate in other clinical studies [17]Individuals who participated in other clinical studies in the past three months [18]Individuals who are or are possibly pregnant, or are lactating [19]Individuals judged inappropriate for the study by the principal
Target sample size	23

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Director
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	t.tamura@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 05 Month 15 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

Management information
Registered date	2016 Year 05 Month 12 Day
Last modified on	2016 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025582