Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

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Allergan

Status

Completed

Conditions

Lip Enhancement

Treatments

Other: No-treatment Control
Device: JUVÉDERM® VOLBELLA® XC with Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519204
VOLBELLA-005

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale.
  • Has the ability to follow study instructions and is likely to complete all required visits

Exclusion criteria

  • Has had any facial procedures or trauma that may interfere with the study procedures and results
  • Is on anti-coagulation therapy or other contraindicated treatments
  • Has current cutaneous inflammatory or infectious processes or lesions in the mouth area

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

176 participants in 2 patient groups

JUVÉDERM® VOLBELLA® XC with Lidocaine
Experimental group
Description:
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips at Day 1. Participants were eligible to receive optional touch-up retreatment one month following initial treatment if applicable.
Treatment:
Device: JUVÉDERM® VOLBELLA® XC with Lidocaine
No-treatment Control
Experimental group
Description:
No-treatment was administered during control period. After 3 months, participants were eligible to receive treatment with JUVÉDERM® VOLBELLA® XC with lidocaine if applicable followed by an optional touch-up retreatment one month following initial treatment.
Treatment:
Device: JUVÉDERM® VOLBELLA® XC with Lidocaine
Other: No-treatment Control

Trial documents
2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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