Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060092) titled 'Effect of the test food on skin elasticity -a randomized, double-blind, placebo-controlled, parallel-group study-' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - DRC Co., Ltd.
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of test food intake on skin elasticity.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of test food for 8 weeks
Interventions/Control_2 - Intake of placebo food for 8 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Female
Key inclusion criteria - (1) Japanese women aged 30-59 years at the time of consent.
(2) Individuals who feel dryness and decreased firmness or elasticity of the skin.
(3) Individuals who received sufficient explanation about the study and voluntarily provided written informed consent.
Key exclusion criteria - (1) Individuals with a history or current diagnosis of chronic diseases such as liver disease, kidney disease, diabetes, or skin disease, or those currently receiving medical treatment or medication.
(2) Individuals with a history of atopic dermatitis or an atopic predisposition.
(3) Individuals who have received cosmetic medical or surgical treatments at the evaluation site within the past 6 months, or plan to do so during the study.
(4) Individuals who have received beauty treatments, massages, or peeling at the evaluation site within the past 4 weeks, or plan to do so during the study.
(5) Individuals who have developed a skin disorder at the evaluation site and received treatment within the past 4 weeks, or plan to do so during the study.
(6) Individuals who continuously use medications, quasi-drugs, health foods, dietary supplements, skincare products, or beauty devices that may affect the study results.
(7) Individuals who have been exposed to excessive ultraviolet light within the past 4 weeks, or plan such exposure during the study.
(8) Individuals with a history of excessive alcohol consumption, drug dependence, or mental illness.
(9) Individuals who smoke regularly.
(10) Individuals with irregular lifestyles due to shift work or sleep disorders.
(11) Individuals with a risk of allergy to the test food.
(12) Individuals who may use medications for seasonal allergies or who have symptoms of skin irritation during the study.
(13) Individuals who plan to change their mask-wearing habits during the study.
(14) Individuals who are pregnant or breastfeeding, or who wish to become pregnant during the study.
(15) Individuals who plan overseas travel, domestic trips, or changes in living environment lasting one week or longer during the study.
(16) Individuals who have participated in another clinical study within the past 4 weeks.
(17) Any other individuals deemed inappropriate by the principal investigator.
Target Size - 88
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 13 Day
Date of IRB - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2025 Year 12 Month 19 Day
Last follow-up date - 2026 Year 03 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068614
Disclaimer: Curated by HT Syndication.
