UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050683 |
|---|---|
| Receipt number | R000057745 |
| Scientific Title | Evaluation of wrinkle improvement |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/12/27 10:51:22 |
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Basic information
Public title
Evaluation of wrinkle improvement
Acronym
Evaluation of wrinkle improvement
Scientific Title
Evaluation of wrinkle improvement
Scientific Title:Acronym
Evaluation of wrinkle improvement
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of wrinkles
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of wrinkle grade
3D analysis of in vivo
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
left-right comparison study
Application of developed product and placebo on each half face
Interventions/Control_2
left-right comparison study
Application of developed product and placebo on each half 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
| 60 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Subjects aged 60 to 79 at the time of informed consent
(2)Subjects who are concerned about wrinkles
(3)Subjects who consent to switch from daily skin items to specified ones
(4)Subjects who spontaneously join the study with written consent after they understand and consent the objective and contents of the study
Key exclusion criteria
(1)Subjects who has factors which can influence the evaluation site (eczema and the like, trauma, acne, tumor, pigmentation, scars, etc.)
(2)Subjects with a history or current history of atopic dermatitis or with a predisposition to atopic dermatitis
(3)Subjects who have undergone or will undergo cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the evaluation area during the examination period
(4)Subjects who have undergone or plan to undergo special skin care procedures (beauty salon, esthetic salon, etc.) on the evaluation site within the past 4 weeks
(5)Subjects who have used medicines (e.g., steroids) as routine skin care for the evaluation site within the past 4 weeks
(6)Subject who has continuously used skin care products, cosmetics, quasi-drugs, or health foods that have efficacy claims similar to or related to the efficacy studied in this study (efficacy against wrinkles and skin whitening)for the evaluated area
(7)Subjects who has changed or started having health foods or using basic cosmetics or sunscreen products for the evaluated area within the past 4 weeks.
(8)Subjects who have been exposed to ultraviolet radiation beyond their daily activities, such as prolonged outdoor work, exercise, swimming, leisure activities, etc., within the past 4 weeks or will be during the study period
(9)Subjects who work night shifts or day/night shifts.
(10)Subjects who have complications and are judged to be poorly controlled by medication or other means, or who are judged to be in need of treatment at the time of consent
(11)Subjects with serious complications or pre-existing medical conditions that make them unsuitable for participation in this study
(12)Subjects with a history of alcohol or drug dependence
(13)Subjects who are at risk of developing allergies to cosmetics (including those who have developed skin problems, such as rashes, with cosmetics within the past year)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyo |
| Middle name | |
| Last name | Noda |
Organization
SUNSTAR Inc.
Division name
R&D
Zip code
658-0032
Address
Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, Japan
TEL
080-9937-4093
hiroyo.noda@jp.sunstar.com
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Yabumi |
Organization
SUNSTAR Inc.
Division name
R&D
Zip code
658-0032
Address
Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, Japan
TEL
080-9937-4102
Homepage URL
natsuki.yabumi@jp.sunstar.com
Sponsor or person
Institute
SUNSTAR Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Shiratori Bldg. 2F 2-1-2 Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel
03-4405-1899
info@brain-care-dementia.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
230112-001
Org. issuing International ID_1
DRC Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 27 | 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
44
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
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057745
