Evaluate the efficacy and safety of MINTLIFT Group for Nasolabial Fold
- Conditions
- Not Applicable
- Registration Number
- KCT0001098
- Lead Sponsor
- Hans Biomed Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) at the time of the screening and at the baseline time point
Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this clinical test
Patients who have a scar or hypertrophic scar or a history of keloid conditions that may affect the determination of effect
Patients allergic to local anesthetics or sleep anesthetics
Patients whose ALT/AST ratio is 2.5 times or more greater than the normal upper limit
Individuals who have been administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening, or who require an anticoagulant during the period of the clinical test
Individuals who have been administered systemic corticosteroids or anabolic steroids within two weeks of the date of the screening or who require their administration during the period of the clinical test (note, however, that the administration of inhaled corticosteroids in a standardized dosage is permissible)
Individuals who have been administered Vitamin E or non-steroidal anti-inflammatory drugs within 1 week of the date of the screening
Individuals who have used Topical liniments in the facial area (steroids, retinoids: only medical drugs are included in this criteria, with the exclusion of cosmetic products) within 4 weeks of the date of the screening or who plan on continuing usage during the period of the clinical test
Individuals who have received wrinkle reduction treatment using Calcium-Hydroxyapatite within 1 year of the date of the screening
Individuals who have received wrinkle reduction treatment using collagen or Hyaluronic Acid filler within 6 months of the date of the screening, or who have received acne treatment, skin regeneration procedures, or cosmetic surgical procedures (including Botox injections) in the facial area
Individuals who have a permanent skin expanding implant such as Softform or silicon inserted in the facial area
Individuals who have scars in the facial area requiring treatment that has not healed for a period of 1 year or longer, or who have a scar or trace in the area on which the clinical test device will applied.
Individuals who have a chronic or recurrent infection or a history of inflammatory disease that may affect this clinical test
Individuals with liver function disorders or coagulation disorders
Individuals who have experienced severe allergies such as symptoms of anaphylaxis
Individuals with decreased immunity
Individuals who exhibit severe impairments in their cardiovascular, digestive, respiratory, endocrine, or central nervous system or who have had or currently have a mental illness that will have a significant effect on this clinical test
Individuals who have participate in another clinical test within 30 days of the date of the screening
Female subjects with the possibility of becoming pregnant during the period of the clinical test who have not consented to a *medically acceptable method of contraception
* Medically acceptable methods of contraception: condoms, oral contraceptives administered for at least three month or longer, the usage of injected or inserted contraceptives, the installation of a contraceptive device within the uterus, etc.
Pregnant women or lactating mothers
In addition to the above, any other individual with clinically significant findings judged to render the individual unsuitable for the test as determined by the test supervisor or other personnel in charge of the test
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of the subjects within the test group who demonstrated wrinkle improvement to -1 or below in Wrinkle Severity Rating Scale as determined by an independent evaluator
- Secondary Outcome Measures
Name Time Method The percentage of the subjects within the test group who demonstrated wrinkle improvement to -1 or below in Wrinkle Severity Rating Scale as determined by an independent evaluator;The percentage of the subjects within the test group who demonstrated wrinkle improvement to -1 or below in Wrinkle Severity Rating Scale as determined by the investigator;The average of the differences between the baseline and the Wrinkle Severity Rating Scale evaluated by the independent evaluator;The average of the differences between the baseline and the Wrinkle Severity Rating Scale evaluated by the subject ;The average value of Global Aesthetic Improvement Scale scores as determined by the investigator and the distribution of scores;The average value of Global Aesthetic Improvement Scale scores as determined by the subject and the distribution of scores;Adverse events;Laboratory test;Physical examination;Concomitant medication