Efficacy and Safety Evaluation of MINT Lift fine for Nasolabial Fold
- Conditions
- Not Applicable
- Registration Number
- KCT0007216
- Lead Sponsor
- Hans Biomed Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
1) Among those who want to improve both nasolabial folds, those who have a Wrinkle Severity Rating Scale (WSRS) of 3 or 4
2) Those who voluntarily sign the research consent form and agree to participate in the clinical trial
3) A person who is willing and able to comply with the test plan
1) Patients with a history of scarring or hypertrophic scarring or keloids that may affect the judgment of effectiveness
2) Patients allergic to local anesthetics
3) Those who have taken anticoagulants (excluding low-dose aspirin (300mg/day)) within 2 weeks from the screening date or those who need to take them during the clinical trial period
4) Those who have used topical application agents (steroids, retinoids: only pharmaceuticals, excluding cosmetics) on the face within 4 weeks from the screening date or are planning to continue using them during the clinical trial period
5) Those who have received wrinkle improvement treatment using CaHA, collagen or HA filler within 6 months from the screening date, or have undergone facial acne treatment, dermabrasion, skin regeneration, or plastic surgery (including botox injection)
6) Those who insert permanent skin extension implants such as softform or silicone in the face
7) Those with uncontrolled active infectious diseases (tuberculosis, hepatitis)
8) Those with weakened immunity
9) Those who participated in other clinical trials within 30 days from the screening date
10) Among female subjects of childbearing potential during the clinical trial period, those who do not agree to use a medically accepted method of contraception* When using an implantable contraceptive, when an intrauterine contraceptive device is installed, etc.)
11) Pregnant women or pregnant women
12) Those who are judged by the researcher to be inappropriate to participate because it may affect other ethical or test results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method