Tokyo, Jan. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060461) titled 'Epidemiological Study Using Test Products' on Jan. 26.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - DHC Corporation
Condition:
Condition - Healthy people
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effects of using the test product on skin condition and deep tissue structure.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use once a day or more for one month.
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - (1) Individuals who participated in the pre-trial and were in their 20s, 40s, or 60s at the time of obtaining consent for the pre-trial
(2) Females
(3) Individuals who have received sufficient explanation regarding the purpose and content of the main trial, possess the capacity to consent, have fully understood the information, voluntarily applied to participate, and are able to provide written consent to participate in the main trial
Key exclusion criteria - (1)deemed ineligible for internal structure examinations by medical institutions.
(2)factors on the evaluation site skin that may affect test results.
(3)history or current condition of atopic dermatitis, or those with an atopic predisposition.
(4)undergone cosmetic medical procedures on the evaluation site, or who plan to undergo such procedures during the test period
(5)received special skincare treatments on the evaluation site within the past 4 weeks, or who plan to receive such treatments during the test period
(6)routinely apply pharmaceuticals or topical medications to the evaluation site
(7)changed or newly started using health supplements, basic cosmetics applied to the evaluation site, or sunscreen within the past 4 weeks
(8)exposed to ultraviolet rays beyond their normal daily activities within the past 4 weeks, or who plan to do so during the trial period
(9)working night shifts or rotating day-night shifts
(10)receiving treatment at medical institutions for disease treatment or prevention at the time of consent acquisition, or individuals judged to be in a condition requiring treatment
(11)history of serious diseases affecting glucose metabolism, lipid metabolism, liver function, kidney function, the circulatory system, respiratory system, endocrine system, immune system, or nervous system
(12)history of alcohol or drug dependence
(13)risk of developing allergies to cosmetics or food (including those who experienced skin abnormalities such as rashes from cosmetics within the past year)
(14)pregnant or breastfeeding at the time of consent acquisition,wish to become pregnant during the trial period
(15)participated in another human trial within the past 4 weeks, or who plan to participate in another human trial during the scheduled period of this trial
(16)silver fillings or dental implants
(17)deemed unsuitable for trial participation by the Principal Investigator (or Investigator)
Target Size - 9
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 22 Day
Anticipated trial start date - 2026 Year 01 Month 26 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069163
Disclaimer: Curated by HT Syndication.
