UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059173 |
|---|---|
| Receipt number | R000067682 |
| Scientific Title | Repeated Application Study of RETISOME IDB Facial Serum |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/24 12:41:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Repeated Application Study of RETISOME IDB Facial Serum
Acronym
Repeated Application Study of RETISOME IDB Facial Serum
Scientific Title
Repeated Application Study of RETISOME IDB Facial Serum
Scientific Title:Acronym
Repeated Application Study of RETISOME IDB Facial Serum
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate improvements in skin and stratum corneum condition following facial application of a serum containing Retisome IDB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VISIA
Key secondary outcomes
･Stratum corneum analysis:Stratum corneum area ,Multiple peeling degree, Stratum corneum roundness, Amount of melanin, Carbonyl protein (CP)
･Measurement equipment:Moisture content measurement (Corneometer), TEWL measurement (Tewameter), Skin viscoelasticity measurement (Cutometer)
･Usability questionnaire
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply the serum twice a day to all faces for 8 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
･Healthy males and females in the age more than 20 and less than 60 years.
･Particpants who are concerned about sagging and wrinkles of skin.
･Particpants who are concerned about spots and dullness of skin.
･Particpants who are concerned about dry skin.
･During the examination period, Particpants who can avoid sun exposure and implement UV protection measures.
Key exclusion criteria
･Participants with alcoholic.
･During the examination period, Participants who plan to begin new beauty treatment (such as esthetic treatment and aesthetic medicine.) and have newly started it within the past two months.
･During the examination period, Participants who plan to change their usual lifestyle habits. (such as starting or stopping a diet and changing sleep habits.)
･Participants with skin conditions. (such as face skin inflammation.)
･Participants who participated in other studies one month prior to the date of consent or scheduled to participate in studies.
･Participants who are pregnant, breastfeeding, or planning pregnancy during the study period.(including immediately after childbirth.)
･Participants with cosmetics allergies or a history of them.
･Participants with hormone replacement therapy.
･Participants with taking treatment a disease and medicine.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Maeda |
Organization
JC Dermatology Laboratory Co., LTD.
Division name
research and development division
Zip code
160-0022
Address
Shinjuku 1-chome Bldg. 8F, 1-10-4 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
TEL
03-3359-5330
d-maeda@jc-dermalabo.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maeda |
Organization
JC Dermatology Laboratory Co., LTD.
Division name
research and development division
Zip code
160-0022
Address
Shinjuku 1-chome Bldg. 8F, 1-10-4 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
TEL
03-3359-5330
Homepage URL
d-maeda@jc-dermalabo.jp
Sponsor or person
Institute
JC Dermatology Laboratory Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
JC Dermatology Laboratory Co., LTD.
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
Tokyo Shinjuku Clinic Ethical Review Board
Address
SIL Shinjuku 5F, 2-46-3, Kabukicho, Shinjuku-ku, Tokyo,Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067682
