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
• 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
• 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

Related Conditions & MeSH terms

• Nasolabial Fold

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