N/A
Completed N=62
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
Lip Augmentation
Source: ClinicalTrials.gov NCT01629134 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Subject Rating of the Natural Look and Feel of the Lips — 52.5; 35.6; 11.9; 0 Percentage of subjects
Summary
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Rating of the Natural Look and Feel of the Lips |
52.5; 35.6; 11.9; 0 | — |
| PRIMARY Injector Rating of the Natural Look and Feel of the Lips |
45.9; 54.1; 0; 0 | — |
| SECONDARY Bruising of the Lips |
85.5; 12.9; 1.6; 0; 0 | — |
| SECONDARY Swelling of the Lips |
38.7; 53.2; 8.1; 0; 0 | — |
| SECONDARY Ease of Injection |
54.8; 45.2 | — |
| SECONDARY Malleability of Product |
45.2; 54.8 | — |
| SECONDARY Need for Massage |
41.9; 58.1; 0; 0 | — |
| SECONDARY Return to Social Engagement |
62.3; 19.7; 9.8; 8.2; 0 | — |
| SECONDARY Comparative Rating With Previous Treatment |
46.2; 53.8; 0; 0; 0 | — |
| SECONDARY Rating of Injection Discomfort |
1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
- Females and males ≥ 18 years of age
- Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results
Exclusion Criteria
- Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
- Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Data sourced from ClinicalTrials.gov (NCT01629134). 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. Informational only — not medical advice.