UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058772 |
|---|---|
| Receipt number | R000067202 |
| Scientific Title | Evaluation study of a cosmetic lotion containing M extract for 24 weeks |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/08/12 17:20:50 |
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Basic information
Public title
Evaluation study of a cosmetic lotion containing M extract for 24 weeks
Acronym
Evaluation study of a cosmetic lotion containing M extract for 24 weeks
Scientific Title
Evaluation study of a cosmetic lotion containing M extract for 24 weeks
Scientific Title:Acronym
Evaluation study of a cosmetic lotion containing M extract for 24 weeks
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of cosmetics containing M extract on wrinkles, skin elasticity, and skin condition after 24 weeks of continuous use will be examined by comparing the effects of the test product with the control product using doctor's evaluation and instrumental measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation by a physician
Stratum corneum moisture content
Skin viscoelasticity
Replica wrinkles
VISIA
Key secondary outcomes
diaryl
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use cosmetics containing M extract for 24 weeks
Interventions/Control_2
Using a placebo cosmetic product for 24 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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following conditions will be selected.
1)Those who have expressed their willingness to participate in the study, understood the explanation, and can provide written consent to participate in the study.
2)Healthy Japanese women aged 35 to 59 who do not meet the exclusion criteria
3)Those who are able to fill out documents such as consent forms, questionnaires, and usage diaries.
4)Those who can come to the designated facility on the measurement day
5)Those who have wrinkles at the corners of the eyes that fall mainly in the range of Grade 3.00 to 5.75 (Journal of the Japanese Society of Cosmetic Science, Vol. 30, No. 4, pp. 316-322, 2006)
6)Those who are aware of a decrease in skin firmness
7)Those who use three or fewer skincare products daily (e.g., lotion, serum, cream) *All-in-one products are excluded
8)Those who agree to their photos being used in media, etc.
Key exclusion criteria
Those who meet any of the following criteria will be excluded.
1)Those with trauma to the area to be measured
2)Those who use cosmetics, quasi-drugs, or medicines that may affect the test
3)Those who have used medicines, quasi-drugs, or cosmetics that claim to have wrinkle improvement or whitening effects on the face within 6 months prior to the start of the study
4)Those who use four or more skin care products after washing their face
5)Those who have undergone cosmetic treatments such as collagen/hyaluronic acid injections, Botox injections, chemical peeling, laser treatment, or phototherapy on the face
6)Those taking hormone medication
7)Those who are likely to be exposed to significant amounts of sunlight during the test period (such as those who play sports during the day for consecutive days)
8)Those who have previously experienced allergic reactions to cosmetics, etc.
9)Those with skin conditions such as atopic dermatitis
10)Subjects with severe hay fever (those who may be taking medication regularly during the study period) and those taking emergency medication will be excluded.
11)Those who regularly drink excessive amounts of alcohol
12)Those with a history of serious liver disease, kidney disease, heart disease, circulatory system disease, or mental illness
13)Those with severe anemia that makes it difficult for them to go out
14)Pregnant or possibly pregnant, breastfeeding, or less than six months after giving birth
15)Those who are currently participating in other clinical trials, or have participated in surveys involving the use of cosmetics, quasi-drugs, or beauty devices within the past four weeks.
16)Those taking medication due to illness
17)Anyone in your family who works for a cosmetics or pharmaceutical company
18)Persons involved in the study (working for the study sponsor or the contracted study organization)
19).Subjects who are otherwise ineligible for participation in this study by the investigater.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Iwakiri |
Organization
Inforward, inc
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
info@inforward.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc
Division name
EBISU skin research center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
Homepage URL
info@inforward.co.jp
Sponsor or person
Institute
Inforward, inc
Institute
Department
Personal name
Funding Source
Organization
Dr's Choice 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
General Incorporated Association Clinical Research Review Center
Address
2972-8-603, Ishikawamachi, Hachioji-chi, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 16 | 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 | 07 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067202
