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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013167
Receipt No. R000015354
Scientific Title A randomized controlled trial for improving effects of "KIMIE WHITE" or "CYSTATHIONE" on skins in women
Date of disclosure of the study information 2014/02/14
Last modified on 2017/01/30

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Basic information
Public title A randomized controlled trial for improving effects of "KIMIE WHITE" or "CYSTATHIONE" on skins in women
Acronym A randomized controlled trial for improving effects on skins in women
Scientific Title A randomized controlled trial for improving effects of "KIMIE WHITE" or "CYSTATHIONE" on skins in women
Scientific Title:Acronym A randomized controlled trial for improving effects on skins in women
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the "KIMIE WHITE" or "CYSTATHIONE" improves skins in women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Skin assessment (Robo Skin Analyzer)
+ fluid
+ lipids
+ brightness
+ number of pigmentation
+ area of pigmentation
+ number of pores
+ number of wrinkle
+ total length of wrinkle
+ total area of wrinkle
+ skin texture
Key secondary outcomes Subjective symptoms measured by Likert scales.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Duration: 12 weeks
Test material: KIMIE WHITE
6 (three times) tablets per day
Interventions/Control_2 Duration: 12 weeks
Test material: CYSTATHIONE
2 capsules per day (940mg/day)
Interventions/Control_3 Duration: 12 weeks
Test material: Placebo
2 capsules per day (940mg/day)
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
60 years-old >
Gender Female
Key inclusion criteria a) Women who are between 40 and 59 years old
b) Persons who are bothering about freckles or ephelides on skin
Key exclusion criteria a) Persons who have previous medical history of malignancy, heart failure, or myocardial infarction
b) Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease
c) Persons who take medicines, herbal medicines, or dietary supplements
d) Persons who are allergic to medicines, or foods related to the test material of this trial
e) Persons who have previous medical history of pollinosis
f) Persons who take dietary supplements or enriched foods
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
i) Persons who are judged not suitable to participate in this trial by physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization JAPANYAKUGEN CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s) TOYAMA JOBIYAKU GROUP Inc.
TO PRETTY CO., LTD.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1401-1312-NY02-05-TC
Org. issuing International ID_1 Ethics Committee of Seishin-kai medical association Inc, Takara medical clinic.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 14 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
2014 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 16 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 01 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015354

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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