UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cosmetics containing material I on the improvement of skin texture
Acronym	Effect of cosmetics containing material I on the improvement of skin texture
Scientific Title	Effect of cosmetics containing material I on the improvement of skin texture
Scientific Title:Acronym	Effect of cosmetics containing material I on the improvement of skin texture
Region	Japan

Condition
Condition	Healthy individual
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of effect of cosmetics containing material I on the improvement of skin texture
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin evaluation indices (moisture content in the stratum corneum, water transpiration amount through the epidermis) 3 measurement time points: Week 0, Week 4, Week 8
Key secondary outcomes	Blemishes, wrinkles, pores, texture, porphyrin, luster, color, rough skin, skin elasticity, collagen, stratum corneum cells, questionnaire

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Lotion containing material I (with material I) Apply the specimens separately to the left and right sides of the face.
Interventions/Control_2	Placebo control (without material I) Apply the specimens separately to the left and right sides of the 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	40 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	(1)The age at the time of obtaining a consent is 20 years or older. (2)Female (3)Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria	Persons who have chronic skin conditions such as atopic dermatitis in the area (face) where the test product is applied Persons who have participated in other clinical trials (drugs) or health food trials and trials where drugs or other substances are applied within the past 3 months Persons with a history of allergies to cosmetics Persons using whitening or anti-wrinkle cosmetics Persons who take beauty supplements and drinks on a daily basis. Persons who have undergone chemical peeling, laser treatment, phototherapy, cosmetic surgery, etc. on their face within 4 weeks prior to the start of the clinical investigation, or those who plan to undergo such treatments during the investigation period. Persons with underlying medical conditions or those undergoing treatment or medication for any disease Patients taking hormone replacement treatment Patients who are pregnant or may become pregnant, and those who are breastfeeding. Persons for whom the study investigator deems unsuitable for participation in the investigation.
Target sample size	13

Research contact person
Name of lead principal investigator	1st name kenta Middle name Last name SHINGAKI
Organization	Noevir Co.,Ltd.
Division name	Groupwide Reseach and Development
Zip code	213-0012
Address	R&D C Building No.333, Kanagawa Science Park(KSP),3-2-1 Sakado, Takatsu-ku, Kawasaki City, Kanagawa
TEL	044-813-2488
Email	tokyolab@n1.noevir.co.jp

Public contact
Name of contact person	1st name yousuke Middle name Last name SHINKAI
Organization	Noevir Co.,Ltd.
Division name	Groupwide Reseach and Development
Zip code	213-0012
Address	R&D C Building No.333, Kanagawa Science Park(KSP),3-2-1 Sakado, Takatsu-ku, Kawasaki City, Kanagawa
TEL	044-813-2488
Homepage URL
Email	tokyolab@n1.noevir.co.jp

Sponsor
Institute	Noevir Co.,Ltd.
Institute
Department

Funding Source
Organization	Noevir Co.,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	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1590
Email	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	2021 Year 10 Month 26 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	13
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	2021 Year 10 Month 07 Day
Date of IRB	2021 Year 10 Month 16 Day
Anticipated trial start date	2021 Year 10 Month 18 Day
Last follow-up date	2021 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 26 Day
Last modified on	2022 Year 04 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051929