NCT01918839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

August 2, 2013

Last Update Submit

December 3, 2023

Conditions

Nasolabial Fold Improvement

Keywords

Investigational Device (VINCI Plus)Correction of nasolabial foldWrinkle improvementWrinkle correction

Outcome Measures

Primary Outcomes (1)

  • Wrinkle Severity Rating Scale (WSRS) Evaluation

    Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks

    At 12 weeks

Secondary Outcomes (3)

  • Wrinkle Severity Rating Scale (WSRS) Evaluation

    At 2 weeks, 6 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

Study Arms (2)

VINCI Plus

EXPERIMENTAL

One side has been treated with VINCI Plus

Device: VINCI Plus

Restylane-L

ACTIVE COMPARATOR

One side has been treated with Restylane-L

Device: Restylane-L

Interventions

VINCI PlusDEVICE

VINCI Plus 1ml injected into wrinkle treatment area

VINCI Plus
Restylane-LDEVICE

Restylane-L injected into wrinkle treatment area

Restylane-L

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 8, 2013

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations

KR(2)