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

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.

Official Title
-----------------
A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

Conditions
-----------------
Lip Enhancement

Intervention / Treatment
-----------------
* Device: JUVÉDERM® VOLBELLA® XC with Lidocaine
* Other: No-treatment Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUVÉDERM® VOLBELLA® XC with Lidocaine<br>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. | Device: JUVÉDERM® VOLBELLA® XC with Lidocaine<br>* JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.<br>|
| Experimental: No-treatment Control<br>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. | Device: JUVÉDERM® VOLBELLA® XC with Lidocaine<br>* JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.<br>Other: No-treatment Control<br>* No-treatment was administered.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3. | Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm) | 
| Procedural Pain Score | Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis. | Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine | 
| Number of Participants With Injection Site Responses (ISRs) | ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis. | Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period. | Baseline to Month 12 Post Treatment |