UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050372 |
|---|---|
| Receipt number | R000057354 |
| Scientific Title | Evaluation of wrinkle improvement test by application of test article P |
| Date of disclosure of the study information | 2023/02/22 |
| Last modified on | 2023/11/29 12:30:13 |
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Basic information
Public title
The wrinkle improvement test of eye care cream
Acronym
The wrinkle improvement test of eye care cream
Scientific Title
Evaluation of wrinkle improvement test by application of test article P
Scientific Title:Acronym
Evaluation of wrinkle improvement test by application of test article P
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of improving wrinkles on the outer corner of the eyes by using the test article for 12 weeks in adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation and photographic image evaluation of wrinkle grade at the eye corner
Wrinkle replica analysis at eye corner
Key secondary outcomes
Subjective evaluation by 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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Left-right comparison study
A group
Left side: test article
Right side: placebo
Each creams are applied twice daily for 12 weeks to the eye corner.
Interventions/Control_2
Left-right comparison study
B group
Left side: placebo
Right side: test article
Each creams are applied twice daily for 12 weeks to the eye corner.
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese women aged 50 to 65 at the time of informed consent
2) Subjects who have wrinkles of grade 3 to 5 on the outer corner of the eyes and wrinkle grade left-right difference of 1 or less
3) Subjects who do not have wounds, warts, pimples, or burns around the corners of the eyes that may affect evaluation measurements
4) Subjects who can be removed double eyelid-forming products when during evaluation
5) Subjects who are concerned about wrinkles at the corners of the eyes
Key exclusion criteria
1) Subjects with significantly different wrinkles on the left and right corners of the eyes
2) Subjects with a history of cosmetics allergies
3) Subjects receiving hormone replacement therapy
4) Subjects who have experience of aesthetic medicine that affects the test site
5) Subjects who are currently attending a dermatological clinic
6) Subjects who are pregnant, potentially pregnant, or breastfeeding
7) Subjects who are participating in other clinical trials
8) Subjects who are excessive exposure to ultraviolet rays
9) Subjects who are planning to become pregnant during the test period
10) Subjects who usually use facial equipment
11) Subjects using eye care creams or gels to improve wrinkles
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Nakaoji |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
6512241
Address
1-3-1, Murotani, Nishi-ku, Kobe, Hyogo, Japan
TEL
078-992-6591
knakaoji@pias.co.jp
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Sahara |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
6512241
Address
1-3-1, Murotani, Nishi-ku, Kobe, Hyogo, Japan
TEL
078-992-6591
Homepage URL
ssahara@pias.co.jp
Sponsor or person
Institute
Pias Corporation
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo,Japan
Tel
03-5408-1599
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
| 2023 | Year | 02 | Month | 22 | 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
36
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 | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | 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 | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057354
