Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement

Not Applicable

Completed

• Conditions: Lip Volume Enhancement
• Interventions: Device: Juvéderm® Volbella with Lidocaine; Device: Restylane-L®

• Registration Number: NCT01579305
• Lead Sponsor: Allergan Medical

Brief Summary

The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2013-06
• Study Completion: 2014-01
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2014-07-10
• Results First Posted: 2014-08-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

1. Desire enhancement of his/her vermilion borders and/or vermilion mucosa
2. 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)
3. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

Exclusion Criteria

1. 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
2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Juvéderm® Volbella with Lidocaine	Juvéderm® Volbella with Lidocaine	Subjects injected with Juvéderm® Volbella with Lidocaine in their lips
Restylane-L®	Restylane-L®	Subjects injected with Restylane-L® in their lips

Primary Outcome Measures

Name	Time	Method
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment	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).