None listed
Conditions
Interventions
Medical Device : (1) Wash before the procedure
(2) Apply a local anesthetic cream to the face where the medical device will be applied 30 minutes to 1 hour before the procedure
(3) Face disinfection a
Sponsors
Hans Biomed Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose wrinkles improved by -1 or less on the WSRS as assessed by an independent rater | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose wrinkles improved by -1 or less on the WSRS as assessed by an independent rater;Wrinkle change values measured with Anterra 3D;Average of differences from baseline before application of WSRS evaluated by independent evaluators;The average value of the Global Aesthetic Improvement Scale (GAIS) evaluated by the tester;The average value of the Global Aesthetic Improvement Scale (GAIS) evaluated by subject | — |
Countries
Korea, Republic of
Contacts
Public ContactJongHo Kim
Seoul National University Bundang Hospital
Outcome results
None listed