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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01579305
First received: April 16, 2012
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention
Lip Volume Enhancement
 Device: Juvéderm® Volbella with Lidocaine
Device: Restylane-L®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Independent Central Reviewer assessment of lip fullness using the Lip Fullness Scale based on 3D photographic images [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject responses on the Recovery Early Life Impact scale of the FACE-Q questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Subject responses on the Recovery Early Symptoms scale of the FACE-Q questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Change in objective measurements of lip volume from baseline to 3 months follow last study treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579305

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

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01579305     History of Changes
Other Study ID Numbers: S15L-003
Study First Received: April 16, 2012
Last Updated: June 17, 2013
Health Authority: France: Committee for the Protection of Personnes
United Kingdom: National Research Ethics Services

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013