Clinical Trial for the evaluation of the efficacy and safety of 7-MEGATM500 on the Skin wrinkle improvement
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0004592
- Lead Sponsor
- Vitech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Adult men and women subjects aged 30 older or under 60
2) The subjects with eye crease grade 3 or higher in visual evaluation
3) The subjects who have agreed to participate in this test prior to the start of the test and have signed a written consent form
1) The subjects who have or are currently undergoing treatment for skin diseases such as atopic dermatitis and psoriasis
2) The subjects who are sensitive or allergic to food for testing
3) The subjects with abnormal skin conditions such as spots, acne, erythema, and capillary dilation in the test area
4) Based on Visit 1, a person who received treatment on the facial (skin stripping, other skin care, etc.) or received treatment on the facial area within 6 months
5) Based on Visit 1, a person who used a skin external substance containing steroids on the facial part or take an oral retinoid/steroid agent within 3 months of the standard visit
6) Based on Visit 1, a person who used functional cosmetic (retinoid agent, retinol, AHA) or moisturizing cosmetic or skin care (LED mask, ion booster, etc.) to improve wrinkles within 2 weeks of visit
7) Based on Visit 1, a person who has taken diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month
8) Based on Visit 1, a person who has taken health function foods containing antioxidants, hyaluronic acids, collagen, freedom of the moon flower, Omega 3, 6 fatty acids such as violet oil, krill oil, persimmon-nolene acid, affluence of manic tree oil (Omega-7), vitamin A, vitamin C, vitamin E, DHA/EPA, and other medicinal products consumed within two weeks
9) Based on Visit 1, a person who has participated in other interventional clinical tests (including human application tests) within one month of the standard or plans to participate in other interventional clinical tests (including human application tests) after the start of this human application test.
10) AST (GOT) or ALT (GPT) or ?-GTP is three times the normal scope of the testing agency
11) Creatine level is more than twice the test institution's
12) TSH 0.1 µIU/ml or 10 µIU/ml or higher
13) Unregulated hypertension patients (based on measurement after 10 minutes of stabilization, at least 160mmHg of the hydraulic pressure or more than 100mmHg of the relaxant blood pressure)
14) Diabetes patients whose blood sugar is unregulated (over 180 mg/dl in public blood)
15) The subjects with schizophrenia, depression, drug addiction, etc.
16)The subjects who are pregnant, nursing, or planning to conceive within three months;
17) Those who are hospitalized, drug treatment, and rehabilitation treatment for alcohol use ·causing disorder, heart disease, and central nervous disorder through a history investigation
18) Smokers or those who smoke less than a year after quitting smoking
19) A person who is deemed inappropriate for this test by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method skin wrinkle
- Secondary Outcome Measures
Name Time Method moisture content of skin