UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study
Title of the study (Brief title)	Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study
Region	Japan

Condition
Condition	Dry skin
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the test food improves skins in women
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Moisture content of the stratum corneum
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test material: supplement containing ceramide(Tablets) 3 tablets one times per day after dinner
Interventions/Control_2	Duration: 8 weeks Test material: plasebo(Tablet) 3 tablets one times per day after dinner
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	Not applicable
Gender	Female
Key inclusion criteria	Women over 40 years old that there is awareness of rough skin due to drying
Key exclusion criteria	-Patients with atopic dermatitis -Under treatment of steroid or anti-allergic agents(including OTC drug). -Patients Moderate or more of allergic rhinitis. -Subjects who have a history of serious disorder. -Subject who are under treatment or supervised by physician. -At the time of the study start persons participating in other clinical trials. -Subjects who are difficult to maintain the lifestyle (diet, sleep, skin care, etc.) -Subjects who are difficult to keep a daily record of symptoms. -Subjects who are pregnant or under lactation. -Subjects who are judged ineligible by our physician.
Target sample size	60

Research contact person
Name of lead principal investigator	Makoto Kawashima
Organization	Tokyo Woman's Medical University
Division name	Dermatology
Address	8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan
TEL	03-3353-8111
Email	m-kawash@derm.twmu.ac.jp

Public contact
Name of contact person	Isako Horiguchi
Organization	EBC&M LLC
Division name	Project planning &Development department
Address	Cross Office Mita 9F 5-9-20, shiba, Minato-ku, Tokyo 108-0041 Japan
TEL	03-6465-3833
Homepage URL
Email	info@ebc-m.com

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	2015 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 15 Day
Anticipated trial start date	2015 Year 01 Month 10 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 22 Day
Last modified on	2017 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018639