UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046821 |
|---|---|
| Receipt number | R000053388 |
| Scientific Title | A study to evaluate the effects of a supplement on skin conditions -Randomized placebo-controlled double-blind parallel group comparison study- |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2022/02/03 17:00:07 |
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Basic information
Public title
A study to evaluate the effects of a supplement on skin conditions
Acronym
A study to evaluate the effects of a supplement on skin conditions
Scientific Title
A study to evaluate the effects of a supplement on skin conditions
-Randomized placebo-controlled double-blind parallel group comparison study-
Scientific Title:Acronym
A study to evaluate the effects of a supplement on skin conditions
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of a supplement on skin conditions in a randomized, placebo-controlled, double-blind, parallel comparison study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture, Skin elasticity, VAS
Key secondary outcomes
Stratum corneum analysis, Collagen content, Blood tests
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take two capsules of the test food orally at breakfast for 8 weeks
Interventions/Control_2
Take two capsules of the placebo food orally at breakfast 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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Japanese females aged of 35-59 years
2)Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
3)Subjects who recognize rough skin caused by dryness at right/left cheek, or right neck, or upper back, or right/left shin, or right instep from October to March every year. Or subjects who have itchiness or subjects who can see flaky skin after bathing
4)Subjects who can quit drinking alcohol during the day before the visit day and after the visit
5)Subjects who can take the test food every day
6)Subjects who concern skin aging (e.g. saggy, skin texture, wrinkle, dry skin, shiny, makeup texture)
7)Subjects who concern skin turn-over
8)Subjects who agreed not to change facial cleansing form, body soap, bath salt, face cosmetics, body milk/cream during this study
9)Subjects who agreed not to shave facial hair 7 days prior to the visit to the clinic
10)Subjects who agreed not to change the facial/body care during this study
11)Subjects who agreed not to receive beauty treatment during this study
Key exclusion criteria
1)Subjects who received beauty treatment within two weeks to this study
2)Subjects who use supplements, foods, and cosmetics which stated the effects on beauty within one month to this study
3)Subjects who are under/will have treatment for pollinosis
4)Subjects at risk for allergy to the test food (e.g. subjects who have a history of allergy to the test food)
5)Subjects at risk for allergy to the content(s) of the test food
6)Subjects who have asthma
7)Subjects who are under dermatological treatment
8)Subjects who have abnormal skin condition(s) on the test area (right/left cheek, right neck, upper back, right/left shin, or right instep)
9)Subjects who have chronic disease(s) and usually use medicine(s)
10)Subjects who are participating in other clinical studies
11)Subjects who are pregnant, or lactation, or may pregnant
12)Subjects who take a medicine or apply an ointment (e.g. medicines for dryness) which may affect the results of this study
13)Subjects who are participating in other clinical studies which use other foods, or medicines, or cosmetics, or who participated such studies in the past three months
14)Subjects who have chronic skin symptom(s) such as atopic dermatitis
15)Subjects who used CoQ10-containing supplements, foods, cosmetics, etc. in the past one month or who plan to use it during this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Funahashi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-6397
Iwao.Funahashi@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Morikawa |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-7673
Homepage URL
Hideyuki.Morikawa@kaneka.co.jp
Sponsor or person
Institute
KANEKA CORPORATION
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053388
