UMIN-CTR Clinical Trial

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