UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042289 |
|---|---|
| Receipt number | R000048279 |
| Scientific Title | Safety and efficacy study of lotion |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2021/05/18 12:21:13 |
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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
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
mkodama@interface-akita.com
Sponsor or person
Institute
Interface, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048279
