None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Individuals aged 35 to 60 years old. 2) Individuals whose wrinkles at both the outer corners of the eyes (left and right) are rated Grade 3 or higher in visual assessment. 3) Individuals whose skin moisture levels at both left and right cheeks (the area where the outer corner of the eyes and the tip of the nose meet at a right angle) are 49 AU or lower in both Visit 1 and Visit 2. 4) Individuals who have agreed to participate in this clinical trial before its start and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary, renal and urinary, nervous, musculoskeletal, infectious diseases, or malignant tumors. 2) Individuals with psychiatric disorders such as schizophrenia, depression, drug addiction, or alcohol use/induced disorders. 3) Individuals with skin diseases such as atopic dermatitis or psoriasis. 4) Individuals with skin abnormalities in the test area, such as moles, acne, erythema, or telangiectasia. 5) Smokers or individuals who have quit smoking for less than 1 year. 6) Individuals who have received botox, filler, or similar procedures on the face within 6 months of Visit 1, or have had laser treatments, skin peeling, or other skincare treatments within 1 month (30 days) of Visit 1. 7) Individuals who have used topical steroid-based skin products on the face within 3 months of Visit 1 or have taken oral retinoid/steroid medications. 8) Individuals who have taken obesity treatment drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric medications for depression and schizophrenia, contraceptives or hormonal treatments, diuretics, or immunosuppressants within 1 month of Visit 1. 9) Individuals who have taken pharmaceutical products or health supplements aimed at improving skin wrinkles or moisturizing (such as antioxidants, hyaluronic acid, collagen, evening primrose oil, and vitamins A, C, E) within 2 weeks of Visit 1. 10) Individuals who have used functional cosmetics for wrinkle improvement (such as retinoid products, AHA, etc.), highly moisturizing/elasticity-enhancing cosmetics, or skin care devices (such as LED masks, ion boosters, etc.) within 2 weeks of Visit 1. 11) Individuals with AST (GOT) or ALT (GPT) levels higher than 120 IU/L or ?-GTP levels higher than 180 IU/L. 12) Individuals with a creatinine level higher than 2.4 mg/dL. 13) Individuals with a TSH level lower than 0.1 µIU/mL or higher than 10 µIU/mL. 14) Individuals with uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg, as measured after 10 minutes of rest during the clinical trial). 15) Individuals with uncontrolled diabetes (fasting blood glucose = 180 mg/dL). 16) Pregnant or breastfeeding women, or individuals planning to become pregnant during the clinical trial period. 17) Individuals who have participated in another interventional clinical trial (including human application studies) within 1 month of Visit 1, or plan to participate in another interventional clinical trial (including human application studies) after the start of this trial. 18) Individuals who are sensitive or allergic to any of the ingredients in the food product for this human application study. 19) Individuals deemed unsuitable for participation by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin wrinkles(visual evaluation, Mark-Vu, PRIMOS CR);Skin moisture | — |
Secondary
| Measure | Time frame |
|---|---|
| Trans-epidermal water loss, Skin elasticity, Skin whitening, Skin radiance, Skin roughness, Eye Wrinkle Volume;Human body Evaluation of the degree of improvement of the tester of the applied test, Assessment of the degree of improvement of the subject of the test for human application;Blood marker(Procollagen-1, Elastin, MMP-1) | — |
Countries
Korea, Republic of
Contacts
Yonsei University Health System, Severance Hospital