Nasolabial Fold Improvement
Conditions
Keywords
Investigational Device (VINCI Plus), Correction of nasolabial fold, Wrinkle improvement, Wrinkle correction
Brief summary
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
Interventions
DEVICEVINCI Plus
VINCI Plus 1ml injected into wrinkle treatment area
DEVICERestylane-L
Restylane-L injected into wrinkle treatment area
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Hospital
D.med
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female between the ages of 30-65, at the point of screening, wrinkles on both sides of treatment area (nasolabial fold) are in the 3rd or 4th level on the WSRS(Wrinkle Severity Rating Score) * Surrounding soft tissue of wrinkles on both sides of nose and lips are sagging * Wrinkles of both sides of nose and lips are visually symmetric * Agrees to stop all other treatment of facial wrinkle improvement including dermatology treatment during clinical trial * Able to understand and follow instructions and participate the entire period of the clinical trial * Subject voluntarily agrees to participate in clinical trial and gives informed written consent
Exclusion criteria
* At the point of screening, intradermal test results show skin irritation to medical devices of clinical trial * Within 2 weeks before the date of screening, subject has taken antithrombotic (with the exception of low dose aspirin 100mg, up to 300mg/day) or non-steroidal anti-inflammatory medication * Case where subject has abnormal liver function or blood coagulation, has to take antithrombotic medication (with the exception of low dose aspirin 100mg, up to 300mg/day) during clinical trial * Subject has used facial topical liniment (steroids, retinoids: excluding only medicines and cosmetics) within 4 weeks before date of screening or plans to continue using facial topical liniment during clinical trial * Within 6 months before date of screening, subject has received anti-wrinkle or acne treatment * Within 6 months before date of screening, subject has received facial microdermabrasion treatment, skin regeneration/rejuvenation treatment, plastic surgery, or cosmetic surgery (including Botox injections) * Within 1 year before date of screening, subject has received CaHA (Calcium Hydroxyapatite) treatment on clinical trial medical device treatment area * Subject has cured facial gel (Softform) or silicone implants inserted as permanent facial expansion * Within 1 year before, subject had an illness that caused scarring or has scars on clinical trial medical device treatment area * Subject has facial skin disease or skin wound infection that affects the clinical trial * Weak immune system or suspect that the immune system is weak * History of anaphylaxis or severe allergic complexity * History of hypertrophic scar or keloid * In the past, if there were adverse effects from EMLA Cream (if EMLA Cream was not used, the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) Evaluation | At 12 weeks | Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) Evaluation | At 2 weeks, 6 weeks | Wrinkle Severity Rating Scale (WSRS) Evaluation at 2 weeks, and 6 weeks. |
| Global Aesthetic Improvement Scale (GAIS) Evaluation | At 2 weeks, 6 weeks and 12 weeks | Global Aesthetic Improvement Scale (GAIS) Evaluation at 2 weeks, 6 weeks and 12 weeks. |
| VAS pain assessment at each time point | at injection and 15, 30, 45, and 60 min after injection | VAS pain assessment at each time point (at injection and 15, 30, 45, and 60 min after injection) |
Countries
South Korea
Outcome results
None listed