UMIN-CTR Clinical Trial

Basic information
Public title	A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Acronym	A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Scientific Title	A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Scientific Title:Acronym	A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine an effect of an anti-wrinkle product for a 12-week application and its safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for evaluating skin condition (doctor's questions and assessment of skin condition(1), photo evaluation(1), skin quality evaluation(1), wrinkle topography(2)). (1)Screening, Week 0, Week 4, Week 8, Week 12. (2)Week 0, Week 4, Week 8, Week 12.
Key secondary outcomes	[1]Questionnaires about skin condition (Week 0, Week 4, Week 8, Week 12). [2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Applying test products (applying test product A [right face] vs applying test product B [left face]).
Interventions/Control_2	Applying test products (applying test product B [right face] vs applying test product A [left face]).
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	55 years-old >=
Gender	Female
Key inclusion criteria	[1]Japanese female aged 35-55 years. [2]Individuals whose wrinkle grade is 3.0 -5.0*. [3]Individuals whose do not apply cosmetics and cuasi-drugs for anti-wrinkle. [4]Individuals who apply 1-3 products for skin care after washing. [5]Individuals who can stop drinking alcohol during the test period. [6]Individuals whose written informed consent has been obtained. *Task Force Committee for Evaluation of Anti-aging Function. Guideline for Evaluation of Anti-wrinkle Products. Journal of Japanese Cosmetic Science Society, 30(4): 316-332, 2006.
Key exclusion criteria	[1]Individuals with chronic skin disease, such as atopic dermatitis. [2]Individuals with strange skin conditions at measurement points. [3]Individuals who had been conducted an operation on the test spot. [4]Individuals who is a patient of hay fever and take a drug. [5]Individuals who were took a special facial treatment in the past 1 month. [6]Individuals who have a habit to ingest supplements claiming for brightening effect. [7]Individuals who cannot avoid daylight exposure during the test period. [8]Individuals who had ingested health-promoting foods, foods for specified health uses, health foods, or supplements being effective for the study. [9]Individuals who have a history of serious heart disease, kidney damage, and endocrine disease. [10]Individuals who conduct or have conducted hormone replacement therapy for menopausal disorder. [11]Individuals who take tabaco or alcohol regularly or whose eating habit is irregularity. [12]Subjects who are pregnant or breast-feeding. [13]Individuals judged inappropriate for the trial by the principal.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Nemoto
Organization	Medical Corporation Kojinkai
Division name	Chief Director
Zip code	064-0807
Address	2-1-4 Minami Nanajo Nishi, Chuo-ku, Sapporo 0640807, JAPAN
TEL	+81-11-221-8807
Email	sapporo@kojinkai.org

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	Derma Labo, Inc.
Institute
Department

Funding Source
Organization	LG Household & Health Care Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Republic of Korea

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@tes-h.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	2019 Year 04 Month 10 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	20
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	2019 Year 03 Month 08 Day
Date of IRB	2019 Year 03 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 11 Day
Last follow-up date	2019 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 06 Day
Last modified on	2019 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041499