Efficacy and Safety of PB203 on the skin wrinkle improvement and moisturizing; Placebo-Clinical trial
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007013
- Lead Sponsor
- Global Medical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Women over the age of 40 and under the age of 60
2) Those whose eye wrinkles are Grade 3 or higher on both the left and right sides in the visual evaluation
3) Those whose moisture retention in both cheeks measured by Corneometer® is 49 AU or less
4) A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
1) 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
2) People with mental disorders such as schizophrenia, depression, drug addiction, alcohol use/induced disorder, etc.
3) Those with skin diseases such as atopic dermatitis and psoriasis
4) Those with skin abnormalities such as spots, acne, erythema, and capillary dilatation at the test site
5) Smokers or those who have not quit smoking for less than 1 year
6) Those who have undergone facial treatment 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)
7) Those who have used steroid-containing skin external agents on the face or oral retinoids/steroids within 3 months from Visit 1
8) 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.
9) Medicines and health functional foods for the purpose of improving skin wrinkles and moisturizing effects 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 functions food, etc.)
10) Those who have used functional cosmetics for wrinkle improvement (retinoids, AHAs, etc.), highly moisturizing cosmetics, or skin care devices (LED mask, ion booster, etc.) within 2 weeks of visit 1.
11) Those with AST (GOT) or ALT (GPT) of 120 IU/L or more or ?-GTP of 180 IU/L or more
12) Those whose Creatinine is 2.4 mg/dL or higher
13) Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more
14) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, measurement standard after 10 minutes of rest for human subjects)
15) Patients with uncontrolled diabetes mellitus (fasting blood sugar 180 mg/dL or higher)
16) Those who are pregnant, lactating, or planning to become pregnant during this human application test period
17) Those who have participated in other interventional clinical trials (including human trials) within 1 month from Visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
18) Those who are sensitive to or allergic to the food ingredients for this human application test
19) 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 (Visual evaluation, Mark-Vu);Skin wrinkles(PRIMOS)
- Secondary Outcome Measures
Name Time Method Transepidermal Water Loss;Skin elasticity;Glossy skin;Eye Wrinkle Volume;Evaluation of improvement for testers and human application test takers