N/A
N=176
Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults
Lip Enhancement
Bottom Line
View on ClinicalTrials.gov: NCT03519204 ↗Enrolled (actual)
176
Serious AEs
2.4%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS) — 0; 84.7 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JUVÉDERM® VOLBELLA® XC with Lidocaine (Device); No-treatment Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS) |
0; 84.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS |
65.0 | — |
| SECONDARY Change From Baseline in Overall Lip Volume |
0.03990; 0.45150 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in Lip Surface Area |
-0.11; 12.16 | <0.0001 sig |
| SECONDARY Procedural Pain Score |
2.6; 2.6 | — |
| SECONDARY Number of Participants With Injection Site Responses (ISRs) |
26; 123; 6; 26 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
3; 74 | — |
Summary
This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.
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
Data sourced from ClinicalTrials.gov (NCT03519204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.