Tokyo, May 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061585) titled 'Effects of the test product on skin condition' on May 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - EP Mediate Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The effects of the test product on skin condition will be evaluated using a placebo as a control.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use Test Item once daily for 8 consecutive weeks
Interventions/Control_2 - Use Control Product once daily for 8 consecutive weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women aged 30 to 64
(2) Individuals who are aware of dry skin and the associated changes in appearance
(3) Individuals who fully understand the purpose and details of the study and consent to participate of their own free will
Key exclusion criteria - (1) Individuals who have undergone cosmetic treatments that may affect the measurement site (e.g., Botox injections, hyaluronic acid injections, collagen injections, etc.)
(2) Individuals who have undergone, or plan to undergo, skin treatments such as facials, body scrubs, or hair removal on the skin of the measurement site between 4 weeks prior to the pre-screening and the end of the study
(3) Individuals who have been, or plan to be, sunburned due to prolonged outdoor work, leisure activities, exercise, etc., between 4 weeks prior to the pre-screening and the end of the study
(4) Individuals who have consumed, or plan to consume, health supplements or medications containing high levels of ceramides, proteoglycans, or placenta at least once a week between 4 weeks prior to the preliminary examination and the end of the study
(5) Individuals at risk of developing an allergy to the test product
(6) Individuals deemed unsuitable as subjects based on the results of the lifestyle questionnaire
(7) Individuals deemed unsuitable as subjects based on the results of the preliminary examination
(8) Other individuals deemed unsuitable as subjects at the discretion of the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 14 Day
Date of IRB - 2026 Year 05 Month 14 Day
Anticipated trial start date - 2026 Year 05 Month 18 Day
Last follow-up date - 2026 Year 08 Month 27 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070461
Disclaimer: Curated by HT Syndication.
