UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy study of lotion
Acronym	Safety and efficacy study of lotion
Scientific Title	Safety and efficacy study of lotion
Scientific Title:Acronym	Safety and efficacy study of lotion
Region	Japan

Condition
Condition	Healthy female
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the safety and efficacy of the test material with plant extract by visual evaluation and bioinstrumentation when applying the test material and placebo on the left or right side of face respectively for 21 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hydration level of stratum corneum(0Weeks,13Weeks, and 21Weeks)
Key secondary outcomes	The activities on 0Weeks,13Weeks, and 21Weeks visits are as follows: Photographs of facial image: VISIA-Evolution (Spots, Brown spots, UV spots, Skintexture, Wrinkles, and Pores) Visual Evaluations Wrinkle Grade Evaluations Photographs of skin image: ANTERA 3D(Spots) Skin color: Chromameter CM-600d Skin color index: Mexameter Trans-epidermal water loss: Vapometer SWL5001JT Skin Viscoelasticity:Cutometer MPA580 Replicas Photographic Evaluations (Spots and Wrinkles)

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	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the test material on the left face and placebo on the right face respectively twice a day for 21 weeks.
Interventions/Control_2	Apply the test material on the right face and placebo on the left face respectively twice a day for 21 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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	(1) Japanese female aged from 40 to 59 years; (2) Subject who is willing to participate in the study and can comply with study requirements; (3) Subject who has any age spots on the left or right side of face; (4) Subject who has "crow's feet" wrinkles of grade 3 to 6 at the corners of both eyes; and (5) Subject who dehydrates face skin in winter.
Key exclusion criteria	(1) Subject who is pregnant or nursing, or is planning to become pregnant or nursing during the study; (2)Subject who used any drug, quasi-drug, or supplements, within 1 month before the baseline visit, that will affect the site to be examined; (3) Subject who has a skin disorder such as atopic dermatitis; (4) Subject who will take any skin care medication that may affect the results of the study; (5) Subject who experienced any cosmetic medication that may affect the results of the study; (6) Subject who is currently taking hormone replacement therapy; (7) Subject who is participating in any other clinical trials; and (8) Subject who otherwise disqualified from participation in the study for any reason at the discretion of the study physician.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kazumi Middle name Last name Nozawa
Organization	Interface, Inc.
Division name	Not applicable
Zip code	010-0001
Address	2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan
TEL	018-827-7155
Email	kazumi.nozawa@interface-akita.com

Public contact
Name of contact person	1st name Miyuki Middle name Last name Kodama
Organization	Interface, Inc.
Division name	Not applicable
Zip code	010-0001
Address	2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan
TEL	018-827-7155
Homepage URL
Email	mkodama@interface-akita.com

Sponsor
Institute	Interface, Inc.
Institute
Department

Funding Source
Organization	Fuji Sangyo, Inc.
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	The ethical committee of Interface, Inc.
Address	2-8-1-7, Nakadori, Akita-shi, Akita, 010-0001, Japan
Tel	018-827-7155
Email	mkodama@interface-akita.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	2020 Year 10 Month 30 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
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 10 Month 16 Day
Date of IRB	2020 Year 10 Month 26 Day
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2021 Year 03 Month 31 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 10 Month 30 Day
Last modified on	2021 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048279