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

N/ACompletedNCT03519204

Allergan176 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

176

Conditions

Lip Enhancement

Interventions

JUVÉDERM® VOLBELLA® XC with LidocaineDEVICE

JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.

No-treatment ControlOTHER

No-treatment was administered.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

General Hospital of Southern Theatre Command

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

China-Japan Friendship Hospital

Beijing, China

Outcomes

Primary Outcomes

Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)

The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

Time frame: Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)

Secondary Outcomes

Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS

Lip fullness was assessed by the participant using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

Time frame: Baseline to Month 3 Post Treatment

Change From Baseline in Overall Lip Volume

Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.

Time frame: Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)

Percentage Change From Baseline in Lip Surface Area

Data from ClinicalTrials.gov

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