Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060059) titled 'A Comparative Application Study of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium on Skin Dryness and Skin Sensitivity' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Xerosis and Sensitive Skin
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the effects of the application of human umbilical cord-derived mesenchymal stem cell conditioned medium to the facial skin of healthy volunteers twice daily for three months on skin dryness and skin sensory hypersensitivity (sensitive skin), including pruritus, based on the hypothesis that improvement in skin dryness may alleviate skin sensitivity.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Application of 0% human umbilical cord-derived mesenchymal stem cell conditioned medium (vehicle only) to the facial skin twice daily after face washing for 3 months.
Interventions/Control_2 - Application of 10% human umbilical cord-derived mesenchymal stem cell conditioned medium to the facial skin twice daily after face washing for 3 months.
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Female
Key inclusion criteria - 1. Healthy females aged between 30 and 59 years
2. Individuals who have never experienced severe sensitive skin or allergic reactions to cosmetics in the past.
3. Individuals who do not have any chronic inflammatory skin diseases.
4. Individuals who, after receiving a sufficient explanation of the study, have fully understood the contents and have provided written informed consent of their own free will.
Key exclusion criteria - 1. Individuals who do not meet the inclusion criteria
2. Individuals whom the principal investigator judges to be inappropriate for participation in this study
Target Size - 45
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 10 Day
Date of IRB - 2025 Year 11 Month 19 Day
Anticipated trial start date - 2025 Year 12 Month 18 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068685
Disclaimer: Curated by HT Syndication.