Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan Medical
- Enrollment
- 285
- Locations
- 2
- Primary Endpoint
- Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
Study Overview
Brief Summary
The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Juvéderm® Volbella with Lidocaine
Subjects injected with Juvéderm® Volbella with Lidocaine in their lips
Intervention: Juvéderm® Volbella with Lidocaine (Device)
Restylane-L®
Subjects injected with Restylane-L® in their lips
Intervention: Restylane-L® (Device)
Outcomes
Primary Outcomes
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
Time Frame: 3 months
The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).
Secondary Outcomes
No secondary outcomes reported