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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039177
Receipt No. 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

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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
Email 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
Email Elizabeth.Tarshish@lycored.com

Sponsor
Institute TTC Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044681

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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