Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
1 other identifier
interventional
176
1 country
5
Brief Summary
This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 26, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedResults Posted
Study results publicly available
June 21, 2019
CompletedAugust 6, 2019
July 1, 2019
2.2 years
April 26, 2018
March 28, 2019
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS
Baseline to Month 3 Post Treatment
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)
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)
Procedural Pain Score
Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine
Number of Participants With Injection Site Responses (ISRs)
Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine
- +1 more secondary outcomes
Study Arms (2)
JUVÉDERM® VOLBELLA® XC with Lidocaine
EXPERIMENTALJUVÉDERM® 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
EXPERIMENTALNo-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.
Interventions
JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (5)
General Hospital of Southern Theatre Command
Guangzhou, Guangdong, 510010, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University Third Hospital
Beijing, 100083, China
Related Publications (1)
Li D, Gao Z, Sun J, Li Q, Jiang P, Zhang L, Chawla S. Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults. Clin Cosmet Investig Dermatol. 2022 Nov 10;15:2427-2436. doi: 10.2147/CCID.S382194. eCollection 2022.
PMID: 36387967DERIVED
Related Links
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Smita Chawla
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2018
First Posted
May 8, 2018
Study Start
January 28, 2016
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
August 6, 2019
Results First Posted
June 21, 2019
Record last verified: 2019-07