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临床试验/KCT0006416
KCT0006416进行中(未招募)未知

A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MKC on the Skin Wrinkle Improvement and Moisturizing

Holistic Bio0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
35?(Year) 至 59?(Year)(—)
性别
Female

入选标准

  • 1) Women over the age of 35 and under the age of 59
  • 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

排除标准

  • 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

研究者

发起方
Holistic Bio

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