N/A
N=281
Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
Lip Volume Enhancement
Bottom Line
View on ClinicalTrials.gov: NCT01579305 ↗Enrolled (actual)
281
Serious AEs
0.7%
Results posted
Aug 2014
Primary outcome: Primary: Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment — 34.1; 29.3 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Juvéderm® Volbella with Lidocaine (Device); Restylane-L® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan Medical
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment |
34.1; 29.3 | — |
Summary
The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
Eligibility Criteria
Inclusion Criteria
- Desire enhancement of his/her vermilion borders and/or vermilion mucosa
- Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)
- Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable
Exclusion Criteria
- Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
Data sourced from ClinicalTrials.gov (NCT01579305). 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.