UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051646 |
|---|---|
| Receipt number | R000058834 |
| Scientific Title | Effect of a horse placental extract-containing cream on the wrinkles in the corner of the eyes of healthy women: a single-blind, comparison study |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2023/07/19 13:54:17 |
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Basic information
Public title
Effect of a horse placental extract-containing cream on the wrinkles in the corner of the eyes of healthy women: a single-blind, comparison study
Acronym
Anti-wrinkle function evaluation test of a horse placental extract-containing eye cream
Scientific Title
Effect of a horse placental extract-containing cream on the wrinkles in the corner of the eyes of healthy women: a single-blind, comparison study
Scientific Title:Acronym
Anti-wrinkle function evaluation test of a horse placental extract-containing eye cream
Region
| Japan |
Condition
Condition
the wrinkles in the corner of the eyes
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
anti-wrinkle effect of a cream formulation containing horse placental extract
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wrinkle grade at the corner of the eye
Trained Expert skilled in wrinkle evaluation performed 8-level wrinkle grade evaluation based on the evaluation criteria and wrinkle grade photo (*) (twice: before the test and 2 weeks after the test)
Key secondary outcomes
Measurement of wrinkles by replica analysis (twice: before the study and 2 weeks after the start of the study)
Rubber-based precision impression material (hydrophilic vinyl silicone impression material) was applied to an area approximately 5 mm away from the subject's eyes, and skin replicas were made of the target area within this range, 10 x 10 mm or larger. The replicas were analyzed using a replica analysis system to calculate the wrinkle area ratio, wrinkle volume ratio, maximum wrinkle depth, maximum wrinkle width, average wrinkle depth, and number of wrinkles.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
During the study period, only the test product is applied to the outer corner of the eye on the side to which the test product is applied. Nothing will be applied to the outer corner of the eyes on the non-application side. No changes or additions of skincare products used in the area other than the corner of the eyes are allowed.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Age 20 or older at the time consent is obtained,59 years of age or younger at the time of consent
2) Wrinkle grade 1 to 3 at the corner of the eyes, mainly on the left and right sides.
3) Skin type III or IV (according to Fitzpatrick's classification)
Key exclusion criteria
1) Those whose left and right eye wrinkle grade scores are markedly different (difference of +/-1.0 or more between left and right eye wrinkle grade)
2) The subject continuously uses skincare products, cosmetics, quasi-drugs, or health foods that claim or emphasize the same or related efficacy (reduction of fine lines and wrinkles due to dryness) as the test product in this study for the evaluation site.
3) Have undergone or plan to undergo cosmetic treatment in the area to be evaluated during the study period.
4) Who have changed or started using health food products or basic cosmetics or sunscreen products for the evaluation site within the past 4 weeks.
5) Who are participating in another study that interferes with this study at the time of study entry or will be participating in another study that interferes with this study during the study's planned duration.
6) Who are undergoing treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of disease or whose condition is judged to be in need of treatment at the time of consent income.
7) Currently undergoing dermatological treatment.
8) Those who work night shifts or day/night shifts
9) Those with a history of alcohol and drug dependence
10) Persons taking alcohol, vitamin B12, melatonin, or other drugs for sleep.
11) Persons at risk of developing allergies to cosmetics or foods (including those who have developed skin rashes or other skin problems with cosmetics within the past year).
12) Pregnant or lactating mothers at the time of consent, or those who wish to become pregnant during the study period.
13) Persons who were deemed unsuitable for participation in the study by the study supervisor or the study administrator (If the study supervisor or the study administrator became aware of facts that made them ineligible in the course of conducting the study, they were excluded from the analysis).
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Iwai |
Organization
Kirei Testing Labo Co., Ltd.
Division name
Head of Examinations
Zip code
135-0047
Address
3F Haseman Bldg., 2-11-6 Tomioka, Koto-ku, Tokyo , Japan
TEL
03-6695-0144
info@kirei-testing-labo.com
Public contact
Name of contact person
| 1st name | Tsuyuko |
| Middle name | |
| Last name | Watanabe |
Organization
Japan Bio Products Co.,Ltd
Division name
Medical Affairs Division
Zip code
151-0063
Address
3F Maple wood 11 bldg., 1-30-22,Tomigaya,Shibuya-ku,Tokyo,Japan
TEL
03-3481-6061
Homepage URL
contact@placenta-jbp.co.jp
Sponsor or person
Institute
Japan Bio Products Co.,Ltd
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
Clinical trial ethics committee
Address
3F Haseman Bldg., 2-11-6 Tomioka, Koto-ku, Tokyo , Japan
Tel
03-5646-2434
d-onuma@saticine-md.co.jp
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
きれいテストラボ株式会社（東京都）/ Kirei Testing Labo Co., Ltd. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
24
Results
The test product was judged to be effective in "reducing the appearance of wrinkles caused by dryness.
Results date posted
| 2023 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
post-registration
Date of the first journal publication of results
Baseline Characteristics
1) Healthy Japanese women who are at least 20 years old and 59 years old or younger at the time of consent
2) Those who have wrinkles grade 1 to 3 at the corner of the eyes, mainly on the left and right sides.
3) Skin type III or IV (according to Fitzpatrick's classification)
Participant flow
The study was initiated with 24 subjects who gave consent; one dropped out, so 23 subjects were included in the analysis.
Adverse events
None
Outcome measures
1) Visual judgment using wrinkle grade standards
2) Wrinkle analysis by instrumental measurement of silicone-based replicas made from the subject area, (Calculation of wrinkle area rate, wrinkle volume rate, maximum depth of wrinkles, maximum width of wrinkles, average depth of wrinkles, and number of wrinkles)
The results were evaluated as valid if there was a significant difference (P < 0.05) in the change in visual wrinkle evaluation values or a significant difference (P < 0.05) in the change in wrinkle analysis parameters by instrumental measurement of the replicas.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 02 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 22 | Day |
Other
Other related information
No URL to post
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058834
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