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

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)

Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.

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)

Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.

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.

Time frame: Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine

Population: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA® XC with Lidocaine.

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.

Time frame: Baseline to Month 12 Post Treatment

Population: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated.

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.

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

Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.

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

Population: mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of the primary variable. As per protocol, analysis for this Outcome Measure was for the Treatment arm only.

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.

Time frame: Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine

Population: Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA®.