UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039177 |
|---|---|
| Receipt number | R000044681 |
| Scientific Title | A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement and its Impact on Skin Parameters in Healthy Female Subjects |
| Date of disclosure of the study information | 2020/01/16 |
| Last modified on | 2021/03/31 16:07:31 |
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Basic information
Public title
A Study Evaluating the Nutritional Supplement on Skin Parameters in Healthy Female Subjects
Acronym
A Study Evaluating the Nutritional Supplement on Skin Parameters
Scientific Title
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Nutritional Supplement and its Impact on Skin Parameters in Healthy Female Subjects
Scientific Title:Acronym
A Study Evaluating the Nutritional Supplement on Skin Parameters in Healthy Female Subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a pilot study, randomized and double blinded designed to evaluate and compare the efficacy of a once a day dietary supplement to reduce the appearance of wrinkles and uneven skin tone and to diminish the appearance of fine lines and wrinkles, to affect skin complexion and texture and to strengthen the skin barrier, over the course of a 12-week use period, and 2 weeks post usage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VISIA
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food daily intake, for 12 weeks
Interventions/Control_2
Intake of placebo daily intake, for 12 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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Subjects must have Fitzpatrick skin Type II or III
Subjects who have Glogau skin classification type II
Key exclusion criteria
Subjects in menopause.
Those on current use or use within 1 month of research enrollment of hormonal therapies.
Those on current regular use or regular use within 1 month of research enrollment of steroids.
Those in chronic or relapsing inflammatory and/or allergic skin conditions.
Pregnant lactating or breastfeeding women.
Subjects who have a history of skin cancer or currently have skin cancer.
Those currently with active herpes infections or currently on treatment for herpes infections.
Those with a history of facial keloids.
Those with current diagnosis of adult acne or currently on treatment for adult acne.
Those with recent cardiovascular conditions.
Those on potent blood thinners.
Those with a current diagnosis of diabetes mellitus.
Those who have received facial irradiation within the last 1 year or are planning on undergoing facial irradiation during the research.
Those with chronic liver disease.
Those with chronic kidney disease.
Those who currently take supplements containing carotenoids.
Those with occupations or lifestyle that require(s) significant daily exposure to the sun.
Subjects who have had previous facial irradiation.
Those who plan to undergo invasive facial procedures.
Those who are HIV positive.
Those who are immunosuppressed.
Those with a recent diagnosis of a psychiatric condition.
Those with chronic connective tissue disorder affecting the skin.
Those with autoimmune skin diseases.
Those who have been prescribed retinoids treatment.
Those who have smoking habits.
Those who take excessive amounts of alcoholic drinks.
Those who use illicit or illegal drugs.
Those who are regular users of cannabis substances or substances derived from cannabis.
Those who are planning a trip to the mountains or to a higher UV index region.
Those who are experiencing perimenopausal or menopausal symptoms.
Those who have had a hysterectomy and/or both of their ovaries removed.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
Numano clinic
Division name
Dermatology
Zip code
150-0013
Address
1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
kaco121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Elizabeth |
| Middle name | |
| Last name | Tarshish |
Organization
Lycored Ltd.
Division name
none
Zip code
8410202
Address
POB 320, Hebron Road, Industrial Zone, Be'er Sheva, Israel
TEL
+972732327323
Homepage URL
Elizabeth.Tarshish@lycored.com
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Lycored 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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.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
| 2020 | Year | 01 | Month | 16 | 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
66
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
| 2020 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044681
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