Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler

NCT ID: NCT01918839

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-06-30

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.

Conditions

Nasolabial Fold Improvement

Keywords

Investigational Device (VINCI Plus); Correction of nasolabial fold; Wrinkle improvement; Wrinkle correction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VINCI Plus

One side has been treated with VINCI Plus

Group Type: EXPERIMENTAL

VINCI Plus

Intervention Type: DEVICE

VINCI Plus 1ml injected into wrinkle treatment area

Restylane-L

One side has been treated with Restylane-L

Group Type: ACTIVE_COMPARATOR

Restylane-L

Intervention Type: DEVICE

Restylane-L injected into wrinkle treatment area

Interventions

VINCI Plus

VINCI Plus 1ml injected into wrinkle treatment area

Intervention Type: DEVICE

Restylane-L

Restylane-L injected into wrinkle treatment area

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

D.med

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DMEDVINCI001

Identifier Type: OTHER

Identifier Source: secondary_id

DMEDVINCI001

Identifier Type: -

Identifier Source: org_study_id