None listed
Conditions
Interventions
Others : The Test Food for this Clinical Trial is probiotics, which is to be taken orally, once a day, 1 capsule at a time with sufficient water for 12 weeks.
The Subjects will be randomly assigned to
Sponsors
AceBiome Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) People over 30 years old and under 70 years old 2) Those whose wrinkles in the left and right corner of the eyes are grade 3 or higher in visual evaluation 3) Those whose skin kin moisture content on the left and right cheeks (right angle intersection between the corner of the eye and the tip of the nose) is 49 AU or less on both Visit 1 and Visit 2 4) A person who agrees to participate in this human application test and fills out a written consent form (Informed Consent Form) before the human application test begins
Exclusion criteria
Exclusion criteria: 1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary systems, kidney and urinary systems, nervous system, endocrine, psychiatric, infectious diseases, and malignant tumors. 2) Patients with mental illnesses such as schizophrenia, depression, drug addiction, alcohol use/induced disorders, etc. 3) People with skin diseases such as atopic dermatitis and psoriasis 4) Those who have skin abnormalities such as moles, acne, erythema, and telangiectasia in the test area 5) Those who have undergone procedures such as botox or filler on the facial area within 6 months of visit 1 6) Those who have used skin exfoliants containing steroids on the face or taken oral retinoids or steroids within 3 months of visit 1 7) Persons who have taken the following medications, received treatment or procedures within 1 month (30 days) of visit 1 ? Obesity treatment drugs (fat absorption inhibitors, appetite suppressants, etc.) ? Psychiatric drugs such as depression and schizophrenia ? Contraceptive pills or hormones ? Diuretics, immunosuppressants ? Facial laser treatment, skin peeling, and other skin care (dermatological procedures and management, etc.) ? Acne treatment (Cleartin, Creocinthi, etc.) 8) Those who used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), high moisturizing/elasticity cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1 9) Those who have taken the following drugs or foods within 2 weeks of visit 1 ? Medicines and health functional foods aimed at improving skin wrinkles and moisturizing effects (antioxidants, hyaluronic acid, collagen, evening primrose oil, medicines and health functional foods containing vitamins A, E, C, etc.) ? Systemic antibiotics, systemic antibacterial agents, colonics ? Probiotics, prebiotics, and lactic acid bacteria products consumed continuously (more than 4 times a week) 10) Those who have no time for outdoor activities at all, or those who plan to travel abroad or on business trips during the human body test period. 11) Excessive smokers (more than 20 cigarettes per day) 12) People with a history of alcohol abuse or who chronically consume alcohol* * Drinking alcohol equivalent to an average of 40 g or more per day (280 g/week) for men and more than 20 g of alcohol per day (140 g/week) for women. 13) Those whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal at the implementing institution 14) Those with TSH less than 0.1 µIU/mL or more than 10 µIU/mL 15) Those with eGFR less than 60 mL/min/1.73 m 2 16) Patients with uncontrolled diabetes (HbA1c greater than 6.5%) 17) Patients with uncontrolled high blood pressure (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher, measured after the subject rests for 10 minutes) 18) Those who are pregnant, lactating, or planning to become pregnant during this human application test period 19) Those who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or who plan to participate in other interventional clinical trials (including human trials) during this human trial period 20) Persons who are sensitive or allergic to the ingredients of this human application test food (test food or control food) 21) A person who is deemed unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin wrinkles (Visual evaluation, Mark-Vu);Skin wrinkles(PRIMOS);skin moisture | — |
Secondary
| Measure | Time frame |
|---|---|
| skin brightness;Skin elasticity;Transepidermal Water Loss;skin texture;Skin pH;tester's evaluation of the improvement;test subject’s Evaluation of the improvement | — |
Countries
Korea, Republic of
Contacts
Public ContactJuhee Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed