Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler

Clinical Study to Evaluate the Efficacy and Safety of Injection With VINCI Plus as Compared to Restylane-L in Correction of Nasolabial Fold

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold Improvement
• Intervention / Treatment: Device: VINCI Plus; Device: Restylane-L

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VINCI Plus; One side has been treated with VINCI Plus	Device: VINCI Plus; VINCI Plus 1ml injected into wrinkle treatment area
Active Comparator: Restylane-L; One side has been treated with Restylane-L	Device: Restylane-L; Restylane-L injected into wrinkle treatment area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation	Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks	At 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation	Wrinkle Severity Rating Scale (WSRS) Evaluation at 2 weeks, and 6 weeks.	At 2 weeks, 6 weeks
Global Aesthetic Improvement Scale (GAIS) Evaluation	Global Aesthetic Improvement Scale (GAIS) Evaluation at 2 weeks, 6 weeks and 12 weeks.	At 2 weeks, 6 weeks and 12 weeks
VAS pain assessment at each time point	VAS pain assessment at each time point (at injection and 15, 30, 45, and 60 min after injection)	at injection and 15, 30, 45, and 60 min after injection

Collaborators and Investigators

• Sponsor: D.med
• Collaborators: Seoul National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimated): August 8, 2013

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Investigational Device (VINCI Plus); Correction of nasolabial fold; Wrinkle improvement; Wrinkle correction
• Other Study ID Numbers: DMEDVINCI001 (Other Identifier: D. Med)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No