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

Not Applicable

Completed

• Conditions: Lip Enhancement
• Interventions: Device: JUVÉDERM® VOLBELLA® XC with Lidocaine; Other: No-treatment Control

• Registration Number: NCT03519204
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-28
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-08
• Results First Submitted: 2019-03-28
• Results First Submitted QC: 2019-03-28
• Results First Posted: 2019-06-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JUVÉDERM® VOLBELLA® XC with Lidocaine	JUVÉDERM® VOLBELLA® XC with Lidocaine	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.
No-treatment Control	JUVÉDERM® VOLBELLA® XC with Lidocaine	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.
No-treatment Control	No-treatment Control	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)	Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)	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.

Secondary Outcome Measures

Name	Time	Method
Procedural Pain Score	Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine	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.
Number of Participants With Injection Site Responses (ISRs)	Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Baseline to Month 12 Post Treatment	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.
Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS	Baseline to Month 3 Post Treatment	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.
Change From Baseline in Overall Lip Volume	Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)	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.
Percentage Change From Baseline in Lip Surface Area	Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)	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.

Trial Locations

Locations (5)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Peking University Third Hospital; 🇨🇳 Beijing, China

General Hospital of Southern Theatre Command; 🇨🇳 Guangzhou, Guangdong, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China