Status:
COMPLETED
Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler
Lead Sponsor:
D.med
Collaborating Sponsors:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Hospital
Conditions:
Nasolabial Fold Improvement
Eligibility:
All Genders
30-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria for subjects applicable)
- History of hypersensitivity to Lidocaine
- Cardiovascular, digestive, respiratory, endocrine, central nervous system disorders that seems clinically significant or had a mental illness that had a significant impact on a previous clinical trial or currently has a mental illness
- Within 30 days before screening, subject participated in other clinical trials
- Female subjects of childbearing potential does not agree to a medically accepted method of contraception for the period of the clinical trial Medically acceptable methods of contraception: condoms; oral contraception continued for at least three months; or if intrauterine is used, installed a contraceptive device
- Pregnant women or nursing mothers
- In addition to the above, the test director or person in charge medically judges there are clinically significant findings that are improper for the clinical trial
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01918839
Start Date
February 1 2014
End Date
June 1 2014
Last Update
December 5 2023
Active Locations (2)
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1
Seoul National University Hospital
Seongnam-si, Gyeonggi-do, South Korea
2
Chung-Ang University Hospital
Seoul, South Korea