UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016031 |
|---|---|
| Receipt number | R000018639 |
| Scientific Title | Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2015/01/10 |
| Last modified on | 2017/06/07 17:59:14 |
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Basic information
Public title
Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study
Acronym
Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study
Scientific Title
Effects of dietary supplement containing ceramide on dry skin: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Makoto Kawashima |
Organization
Tokyo Woman's Medical University
Division name
Dermatology
Zip code
Address
8-1 Kawada-cho,Shinjyuku-ku,Tokyo 162-8666,Japan
TEL
03-3353-8111
m-kawash@derm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isako Horiguchi |
Organization
EBC&M LLC
Division name
Project planning &Development department
Zip code
Address
Cross Office Mita 9F 5-9-20, shiba, Minato-ku, Tokyo 108-0041 Japan
TEL
03-6465-3833
Homepage URL
info@ebc-m.com
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018639
