Efficacy and Safety of Elastin of bonito on the skin wrinkle improvement and moisturizing; Placebo-Clinical trial
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007453
- Lead Sponsor
- Global Medical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
men and women over 35 and under 60
In the visual evaluation, a person whose eye wrinkles are Grade 3 or higher on both the left and right sides
Those with a water retention of 49 AU or less in both cheeks as measured by Corneometer® at visits 1 and 2
A person who has consented to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
Those who are currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease or malignancy
People with mental disorders such as schizophrenia, depression, drug addiction, alcohol use/induced disorder, etc.
Those with skin diseases such as atopic dermatitis and psoriasis
Those with skin abnormalities such as spots, acne, erythema, and capillary dilatation at the test site
Smokers or those who have quit smoking for less than 1 year
Those who have undergone facial procedures such as botox or fillers within 6 months of visit 1, or who have undergone facial skin dermabrasion or other skin care within 1 month (30 days)
Those who have used steroid-containing skin external agents on the face or oral retinoids/steroids within 3 months of visit 1
Those who have taken anti-obesity drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives or hormones, or diuretics within 1 month of visit 1
Medicines and health functional foods for skin wrinkle improvement and moisturizing effect within 2 weeks of visit 1 (health functional foods containing antioxidants, hyaluronic acid, collagen, evening primrose oil, vitamins A, C, E containing medicines and health functional foods, etc.) ) ingested
Those who have used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1.
Those with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more
Those with a creatinine of 2.4 mg/dL or higher
Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more
Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement standard after 10 minutes of rest for human subjects)
Patients with uncontrolled diabetes mellitus (fasting blood sugar >180 mg/dL)
Those who are pregnant, lactating, or planning to become pregnant during this human application test period
Those who have participated in other interventional clinical trials (including human trials) within 1 month of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
Those who are sensitive to or allergic to the food ingredients for this human application test
Those who are judged inappropriate by the investigator for other reasons
Those who are currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease or malignancy
People with mental disorders such as schizophrenia, depression, drug addiction, alcohol use/induced disorder, etc.
Those with skin diseases such as atopic dermatitis and psoriasis
Those with skin abnormalities such as spots, acne, erythema, and capillary dilatation at the test site
Smokers or those who have quit smoking for less than 1 year
Those who have undergone facial procedures such as botox or fillers within 6 months of visit 1, or who have undergone facial skin dermabrasion or other skin care within 1 month (30 days)
Those who have used steroid-containing skin external agents on the face or oral retinoids/steroids within 3 months of visit 1
Those who have taken anti-obesity drugs (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives or hormones, or diuretics within 1 month of visit 1
Medicines and health functional foods for skin wrinkle improvement and moisturizing effect within 2 weeks of visit 1 (health functional foods containing antioxidants, hyaluronic acid, collagen, evening primrose oil, vitamins A, C, E containing medicines and health functional foods, etc.) ) ingested
Those who have used functional cosmetics for wrinkle improvement (retinoids, AHA, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1.
Those with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more
Creatinine of 2.4 mg/dL or higher
Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more
Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measurement standard after 10 minutes of rest for human subjects)
Patients with uncontrolled diabetes mellitus (fasting blood sugar >180 mg/dL)
Those who are pregnant, lactating, or planning to become pregnant during this human application test period
Those who have participated in other interventional clinical trials (including human trials) within 1 month of Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
Those who are sensitive to or allergic to the food ingredients for this human application test
Those who are judged inappropriate by the investigator for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method skin wrinkles; skin moisture
- Secondary Outcome Measures
Name Time Method transdermal water loss; skin elasticity; Whitening;Eye Wrinkle Volume;Evaluation of the improvement of the tester in the human application test;Evaluation of improvement of subjects in human application test