Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062834) titled 'Effect of the test food on skin elasticity -a randomized, double-blind, placebo-controlled, parallel-group study-' on Sept. 10.
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 - Specified skincare products (from the run-in period) + test food for 8 weeks
Interventions/Control_2 - Specified skincare products (from the run-in period) + placebo food for 8 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Female
Key inclusion criteria - (1) Japanese women aged 30-49 years at the time of informed consent.
(2) Individuals who feel dryness and decreased firmness or elasticity of the skin.
(3) Individuals who have used toner and emulsion for skincare prior to informed consent, have not used serums, creams, or other similar skincare products, and agree to use only the specified skincare products throughout the study period.
(4) Individuals who received sufficient explanation about the study and voluntarily provided written informed consent.
Key exclusion criteria - (1) History of or current diagnosis of chronic diseases such as liver disease, kidney disease, diabetes, or skin disorders, or current medical treatment or medication use.
(2) History of atopic dermatitis or atopic predisposition.
(3) History of allergies to cosmetics or topical medicinal products.
(4) Cosmetic medical or surgical procedures at the evaluation site within the past 6 months, or plans to undergo such procedures during the study.
(5) Beauty treatments, massages, or peeling procedures at the evaluation site within the past 4 weeks, or plans to undergo such treatments during the study.
(6) Skin disorders at the evaluation site treated within the past 4 weeks, or plans to receive such treatment during the study.
(7) Continuous use of medications, quasi-drugs, health foods, dietary supplements, skincare products, beauty devices, or other products that may affect study results.
(8) Ultraviolet exposure exceeding usual daily exposure within the past 4 weeks, or plans for such exposure during the study.
(9) History of excessive alcohol consumption, drug dependence, or psychiatric disorders.
(10) Regular smokers.
(11) Irregular lifestyles due to shift work, sleep disorders, or other reasons.
(12) Risk of developing an allergy related to the study.
(13) Potential need for medication for seasonal allergies during the study, or subjective symptoms of skin irritation.
(14) Planned change in usual mask-wearing habits during the study.
(15) Pregnancy, breastfeeding, or plans to become pregnant during the study.
(16) Planned overseas travel, domestic business trips or vacations lasting 1 week or longer, or changes in living environment during the study.
(17) Participation in another clinical study within the past 4 weeks.
(18) Considered unsuitable for participation by the principal investigator.
Target Size - 110
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 31 Day
Date of IRB - 2026 Year 08 Month 06 Day
Anticipated trial start date - 2026 Year 09 Month 11 Day
Last follow-up date - 2026 Year 12 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071902
Disclaimer: Curated by HT Syndication.
