UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063298 |
|---|---|
| Receipt number | R000072453 |
| Scientific Title | Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation. |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/15 17:43:49 |
* 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
Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation.
Acronym
Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation.
Scientific Title
Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation.
Scientific Title:Acronym
Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effects on skin condition (moisturization, firmness and elasticity, skin brightness and complexion, barrier function, etc.) resulting from continuous application of the test product in the morning and after bathing for 12 weeks and compare these results with those of the control product applied to the same areas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum hydration
Skin color(L*a*b*)
Skin viscoelasticity
Key secondary outcomes
Transepidermal water loss
Stratum corneum characteristics(cell area, multiple-layered desquamation, and SH/SS staining)
Image analysis
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Factorial
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
The Bis-glutathione trisulfide formulation is applied daily for 12 weeks.
Interventions/Control_2
Placebo formulation is applied daily for 12 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who are aware of skin issues such as dryness or dullness.
Individuals whose daily skincare routine after washing their face (or bathing) consists of a simple regimen of only 1 to 2 products, such as toner, moisturizer, or an all-in-one product.
Individuals confirmed to have minimal left-right asymmetry based on color difference measurements taken during the screening examination.
Individuals who have received a thorough explanation of the purpose and details of this trial, possess the capacity to give informed consent, have voluntarily applied to participate after fully understanding the trial, and are able to provide written consent to participate in this trial.
Key exclusion criteria
Skin conditions or marks at the evaluation site that may affect results, including hives, inflammation, eczema, injuries, acne, pimples, warts, or dark spots.
Current or past atopic dermatitis, a blood relative with the condition, or atopic predisposition such as dust mite or house dust allergies.
Past or planned cosmetic medical procedures at the evaluation site during the study.
Special skincare treatments at the evaluation site within the past 4 weeks or planned during the study.
Routine use of creams, gels, serums, face masks, or oils at the evaluation site.
Routine use of skincare products containing sulfur compounds, sulfur-spring water, or glutathione.
Routine use of quasi-drugs claiming skin-whitening effects at the evaluation site.
Regular use of supplements containing glutathione, broccoli extract, or broccoli sprout extract.
Changes to or new use of supplements, basic skincare products, or sunscreen within the past 4 weeks.
Unusually high UV exposure within the past 4 weeks or planned during the study.
Night or rotating shift workers.
Those whose daily work involves driving.
Medical treatment for disease prevention or treatment at consent, or deemed to require such treatment.
Current or past severe diseases affecting carbohydrate or lipid metabolism, liver or kidney function, or the cardiovascular, respiratory, endocrine, immune, or nervous systems.
History of alcohol or drug dependence.
Risk of allergies to cosmetics or food, including cosmetic-related skin reactions within the past year.
Pregnancy or breastfeeding at consent, or plans to become pregnant during the study.
Participation in another human study within the past 4 weeks or planned participation during this study.
Individuals deemed unsuitable by the principal investigator or other authorized personnel.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Inoue |
Organization
YAWARA Dermatology Clinic
Division name
Director
Zip code
5300041
Address
4F, Sakashin Tenjinbashi Building, 5-7-10 Tenjinbashi, Kita-ku, Osaka-shi, Osaka, 530-0041 Japan
TEL
06-6882-1130
yuyosei@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shimmyo |
Organization
Mitsubishi Corporation Life Sciences Limited
Division name
Development Group, Cosmetic Division
Zip code
100-6605
Address
5F, GranTokyo South Tower, 1-9-2 Marunouchi, chiyoda-ku, Tokyo 100-6605 Japan
TEL
03-6386-9355
Homepage URL
takahiro.shimmyo@mcls-ltd.com
Sponsor or person
Institute
Mitsubishi Corporation Life Sciences Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
Brain Care Clinic Ethics Review Committee
Address
2F, Shiratori Building, 2-1-2 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
Tel
06-6882-1130
ethics_board@drc-web.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | 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
| 2026 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072453
