Clinical trial NCT01918839: Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler
Official title: Clinical Study to Evaluate the Efficacy and Safety of Injection With VINCI Plus as Compared to Restylane-L in Correction of Nasolabial Fold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Fold Improvement
Keywords: Investigational Device (VINCI Plus)
Correction of nasolabial fold
Wrinkle improvement
Wrinkle correction
Lead sponsor: D.med
Sponsor class: INDUSTRY
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Seoul National University Hospital
First posted: 2013-08-08
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) Evaluation
timeFrame: At 12 weeks
Secondary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) Evaluation
timeFrame: At 2 weeks, 6 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Evaluation
timeFrame: At 2 weeks, 6 weeks and 12 weeks
measure: VAS pain assessment at each time point
timeFrame: at injection and 15, 30, 45, and 60 min after injection
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References: