UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035212 |
|---|---|
| Receipt number | R000040055 |
| Scientific Title | Improvement of the skin quality through the combination of foods and cosmetics |
| Date of disclosure of the study information | 2018/12/11 |
| Last modified on | 2019/07/08 14:31:37 |
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Basic information
Public title
Improvement of the skin quality through the combination of foods and cosmetics
Acronym
Improvement of the skin quality through the combination of foods and cosmetics
Scientific Title
Improvement of the skin quality through the combination of foods and cosmetics
Scientific Title:Acronym
Improvement of the skin quality through the combination of foods and cosmetics
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the improvement of the skin quality from using the combination of both foods (supplement) and cosmetics (cosmetic)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes for skin conditions (stratum corneum moisture content, transepidermal water loss) and questionnaire (water amount, drying)
Key secondary outcomes
score of spots, wrinkles, pores, texture, porphyrin, ultraviolet ray spot, red and brown spots, transepidermal water transpiration amount, skin elasticity, multiple peeling rate, stratum corneum cell area, oxidative stress, glycation degree, special urine Inspection and questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
Apply test cosmetics (gel) continuously for 4 weeks
Interventions/Control_2
Apply test cosmetics (lotion, cream) continuously for 4 weeks
Interventions/Control_3
Apply test cosmetics (lotion, cream) continuously for 4 weeks, and take the test food continuously for 4 weeks
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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Age range is between 40 years old and under 60 years old
(2) female
(3) Candidates with voluntary informed consents
Key exclusion criteria
1.Those who are allergic to the raw materials of the test food 2.Those who are taking foods stated to contain ingredients in the subject food 3.Those who are taking dietary supplements 4.Those who have skin conditions that may affect the results of the test on the skin 5.Those who have experienced skincare treatment at the evaluation site, or who are planned to receive it during the examination period 6.Those who have received special skincare treatment on the evaluation site within the past 4 weeks or are scheduled to receive during the examination period 7.Those who are continuously using skincare products or health foods that enhance the efficacy similarly to the effects being examined in this study 8.Those who have changed the skincare products or sunscreen agents used on the evaluation site within the past 4 weeks, or newly started 9.Night-shift and/or day-shift workers 10.Those who are receiving treatments at a medical institution or alike for treatment 11.Those who have a history of serious diseases or psychiatric disorders of glucose metabolism, lipid metabolism, liver function, etc. and nervous system 12.Those who have a history of alcohol and drug dependency 13.Those who are at risk of developing allergy to cosmetics and foods (including those who have developed skin abnormalities, such as rash within the past year) 14.Those who are pregnant, breast-feeding at the time of acquiring consent, or who desire pregnancy during the examination period 15.Those who have participated in other human tests within the past 4 weeks or who are planning to participate in other human examinations during the study scheduled period 16.Those who are judged by the investigator (or the person responsible for conducting the examination) to be inappropriate for participating in the examination
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corpoation Kenshokai
Fukushima Healthcare Center
Division name
Medical Corpoation Kenshokai Fukushima Healthcare Center
Zip code
553-0004
Address
2-12-16, Tamagawa Fukushima-ku, Osaka, Japan
TEL
81-(0)6-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Yatsuhashi |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of Health Sciences
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL
+81-6-6477-8425
Homepage URL
hiroko.yatsuhashi@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
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
Kensho-kai Institutional Review Board
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka
Tel
81-(0)6-6882-1130
ethics_board@drc-web.co.jp
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
| 2018 | Year | 12 | Month | 11 | 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
34
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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040055
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