Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062753) titled 'Exploratory Study of Changes in Skin Function Following Intake of Ume Extract Umulin' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Wakayama Medical University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To exploratively assess changes in subjective indicators of skin condition in healthy adults following 8 weeks of oral intake of ume extract and to obtain basic data for future confirmatory studies.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral intake of 7.2 g of ume extract (Umulin) concentrate once daily for approximately 8 weeks.
Eligibility:
Age-lower limit - 25
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Men and women aged 25 to 60 years who are judged by the principal investigator to have no apparent skin disease.
2.Individuals who have received sufficient explanation regarding the purpose, methods, study period, and questionnaire procedures of the study, understand the contents, and provide written informed consent of their own free will.
3.Employees, trainees, or students affiliated with Wakayama Medical University who do not meet any of the exclusion criteria.
Key exclusion criteria - 1.Individuals undergoing treatment for severe skin disease.
2.Individuals considered unable to participate continuously throughout the study period.
3.Individuals concurrently participating in another skin-related clinical study.
4.Individuals with a history of hypersensitivity or allergy to Umulin.
5.Employees of Kishu Hosokawa Co., Ltd.
6.Staff members of the Department of Dermatology, Wakayama Medical University.
7.Staff members, trainees, or students involved in dermatological clinical practice or research at Wakayama Medical University.
8.Individuals involved in the conduct, evaluation, analysis, or decision regarding publication of the results of this study.
9.Individuals judged by the investigator to be unsuitable for participation in the study for any other reason.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 12 Day
Anticipated trial start date - 2026 Year 09 Month 15 Day
Last follow-up date - 2026 Year 11 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071844
Disclaimer: Curated by HT Syndication.