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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01579305
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : August 5, 2014
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )

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

Condition or disease Intervention/treatment Phase
Lip Volume Enhancement Device: Juvéderm® Volbella with Lidocaine Device: Restylane-L® Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : January 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Juvéderm® Volbella with Lidocaine
Subjects injected with Juvéderm® Volbella with Lidocaine in their lips
 Device: Juvéderm® Volbella with Lidocaine
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
Active Comparator: Restylane-L®
Subjects injected with Restylane-L® in their lips
 Device: Restylane-L®
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579305


Locations
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France
Cannes, France
United Kingdom
Glasgow, United Kingdom
Sponsors and Collaborators
Allergan Medical
More Information
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Publications:

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Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01579305    
Other Study ID Numbers: S15L-003
First Posted: April 17, 2012    Key Record Dates
Results First Posted: August 5, 2014
Last Update Posted: January 17, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action