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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025667
Receipt No. R000029527
Scientific Title A study on the dermatological efficacy of oral administration of beauty capsule
Date of disclosure of the study information 2017/01/18
Last modified on 2017/05/30

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Basic information
Public title A study on the dermatological efficacy of oral administration of beauty capsule
Acronym Evaluation of beauty ingredient for skin
Scientific Title A study on the dermatological efficacy of oral administration of beauty capsule
Scientific Title:Acronym Evaluation of beauty ingredient for skin
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the dermatological efficacy of beauty capsule for healthy female
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of skin properties, e.g. skin color, transepidermal water loss, and skin hydration and blood parameters before and after capsule intake.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of active capsules twice a day for 8 weeks
Interventions/Control_2 Oral intake of placebo capsules twice a day for 8 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
25 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria Healthy female suffered from red skin
Key exclusion criteria -Subjects who go to hospital regularly or went to hospital within the past 1 month for disease: skin, gastrointestinal system, liver, kidney, heart, blood pressure, and physical deconditioning. (Manual therapeutics, chiropractic and massage are not included.)
-Subjects who are routinely taking oral medicine or applying external use medicine (ex. hypnotic, analgesic, anti-histamine, rhinitis drug, hormone preparation, cathartic, intestinal regulator, and others).
-Subjects who have received medical cosmetic treatment before.
-Subjects who have food or drug allergies.
-Subjects who are pregnant, could be pregnant in near future, or are breast feeding.
-Subjects who are participating in another clinical study.
-Subjects who are deemed inappropriate to participate in this study by the principle investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd
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 株式会社SOUKEN(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 18 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
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 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
2017 Year 01 Month 13 Day
Last modified on
2017 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029527

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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