Placebo-Controlled Clinical Trial of Efficacy and Safety of MC01 on the Skin Wrinkle Improvement and Moisturizing
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007499
- Lead Sponsor
- Maeil Health Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) men and women between the ages of 40 and 60
2) In visual assessment, Those with grade 3 or higher on both the left and right eye wrinkles
3) Those with water retention of both cheeks measured with Corneometer® of 49 AU or less in visit 1and visit 2
4) Befor Clinicla Trial, A person who agrees to participate in Clinical Trial, and write informed consent form.
1) Persons currently being treated for severe cardiovascular, immune, respiratory system, gastrointestinal/hepatic and biliary systems, kidney and urological systems, nervous system, musculoskeletal system, infectious diseases and malignancies
2) A person with mental illness such as schizophrenia, depression, drug addiction, alcohol use/inducing disorder, etc
3) People with skin diseases such as atopic dermatitis and psoriasis
4) Those who have skin abnormalities such as spots, acne, erythema, capillary dilatation, etc. in the test area
5) Smokers or persons less than one year after smoking cessation
6) A person who has undergone a procedure such as Botox, filler, etc. on the face within 6 months of visit 1 or has undergone laser treatment, skin peeling, or other skin care on the face within 1 month (30 days)
7) A person who has used a steroid-containing skin exoplasmic agent in the facial area or has taken an oral retinoid/steroid within 3 months of visit 1
8) A person who has taken obesity treatments (fat absorption inhibitors, appetite suppressants, etc.), psychiatric drugs such as depression and schizophrenia, contraceptives or hormone drugs, or diuretics within one month of visit 1
9) A person who has taken medicines and health functional foods (antioxidants, hyaluronic acid, collagen, moonflower seed oil, vitamins A, C, E-containing medicines and health functional foods) within 2 weeks of visit 1
10) A person who has used functional cosmetics (retinoid agents, AHA, etc.), high-moisturizing cosmetics, or skin care devices (LED masks, ion boosters, etc.) to improve wrinkles within 2 weeks of visit 1
11) A person with an AST (GOT) or ALT (GPT) of 120 IU/L or more or a ?-GTP of 180 IU/L or more
12) A person who has a Creatine content of 2.4 mg/dL or more
13) A Persons with TSH of 0.1 µIU/mL or Less or more than 10 µIU/mL
14) an uncontrolled hypertensive patient(Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, Measurement criteria after 10 minutes of stabilization)
15) an uncontrolled diabetic(Not less than 180 mg/dL of fasting blood sugar)
16) a pregnant or lactating woman or A person who has a pregnancy plan during this Clinical Trial period
17) Those who have participated in other clinical trials within one month of visit 1 or who have plans to participate in other clinical trials since the start of this human application test
18) A person who is sensitive or allergic to investigator's product and lactose for this Clinical Trial.
19) A person who determines that the tester is unfit for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skin Wrinkle;skin moisture content
- Secondary Outcome Measures
Name Time Method transdermal water loss;Skin Elasticity;Eye Wrinkle Volume;dermal density;Evaluation of the investigator's improvement ;Evaluation of the subject's improvement