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Completed

NCT Number: NCT02558283

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

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

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Key information

Conditions

Nasolabial Fold

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Japan Friendship Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JUVÉDERM® VOLIFT® with Lidocaine

Device

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®

Device

Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.

Primary outcomes

  1. Investigator's Assessment of Severity of Each Nasolabial Fold (NLF) on the 5-Point NLF Severity Scale (NLFSS)

    Time frame: Month 6

Secondary outcomes

  1. Subject's Assessment of Procedural Pain on an 11-Point Scale

    Time frame: Day 1

  2. Investigator's Assessment of Each NLF on the 5-Point Global Aesthetic Improvement Scale (GAIS)

    Time frame: Month 6

  3. Subject's Assessment of Each NLF on the 5-Point GAIS

    Time frame: Month 6

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2015
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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