Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips | NCT01629134 | Trialant
CompletedObservationalUpdated Oct 13, 2014
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
ClinicalTrials.gov ID
NCT01629134
Lead Sponsor
Allergan MedicalINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
62Actual
Last Update Posted
Oct 13, 2014Estimated
Start Date
Jun 2012
Primary Completion Date
Dec 2012Actual
Completion Date
Dec 2012Actual
Brief Summary
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
Lip Augmentation
Crosslinked hyaluronic acid gel
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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