Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063298) titled 'Study to evaluation the skin quality improvement effects of 12 weeks continuous use of Bis-Glutathione Trisulfide formulation' on Oct. 20.
Study Type:
Interventional
Study Design:
Basic Design - Factorial
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Mitsubishi Corporation Life Sciences Limited
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 30
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072453
Disclaimer: Curated by HT Syndication.