UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025667 |
|---|---|
| Receipt number | 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 08:33:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029527
