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

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

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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