KCT0007013Recruiting未知
A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PB203 on the Skin Wrinkle Improvement and Moisturizing
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 40?(Year) to 60?(Year) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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