Clinical Trials Logo
  1. Home
  2. Nasolabial Fold
  3. NCT02558283
  4. Details
NCT02558283 Clinical Trial

A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

Nasolabial Fold Clinical Trial

Official title:
A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02558283
Other study ID # VOLIFT-002
Secondary ID
Status Completed
Phase N/A
First received September 22, 2015
Last updated August 28, 2017
Start date January 25, 2016
Est. completion date June 19, 2017

Study information
Verified date August 2017
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date June 19, 2017
Est. primary completion date June 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presence of nasolabial folds

- Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study

Exclusion Criteria:

- Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study

- Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study

- Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• JUVÉDERM® VOLIFT® with Lidocaine
JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
• Restylane®
Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Locations
Country Name City State
China China Japan Friendship Hospital Beijing
China Peking University Third Hospital Beijing
China General Hospital of Guangzhou Military Command of PLA Guangzhou
China Union Hospital Tongji Medical College Huazhong University of Science and Technology Guangzhou
China Shanghai 9th Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS) Month 6
Secondary Subject's Assessment of Procedural Pain on an 11-Point Scale Day 1
Secondary Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS) Month 6
Secondary Subject's Assessment of Each NLF on the 5-Point GAIS Month 6
See also
  Status Clinical Trial Phase
Completed NCT04128046 - The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation N/A
Completed NCT03174132 - Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds N/A
Completed NCT03300466 - A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds N/A
Recruiting NCT01848717 - Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold N/A
Active, not recruiting NCT04534660 - Preliminary Safety and Effectiveness of SMI-01 as a Tissue Filler N/A
Active, not recruiting NCT04839484 - LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds N/A
Completed NCT04754646 - RHA® 4 NLF Cannula N/A
Active, not recruiting NCT03844529 - Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds N/A
Completed NCT02176356 - Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study) Phase 4
Completed NCT01775293 - Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh N/A
Completed NCT01585220 - Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold Phase 3
Completed NCT02918721 - Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds N/A
Completed NCT05294562 - China Post-Market Clinical Follow-up of FACILLE®
Recruiting NCT04957446 - Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) N/A
Completed NCT04569045 - Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds N/A
Recruiting NCT04224649 - To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds N/A