We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629134
First Posted: June 27, 2012
Last Update Posted: October 13, 2014
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.
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
  Purpose
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.

Condition Intervention
Lip Augmentation Device: Crosslinked hyaluronic acid gel

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan ( Allergan Medical ):

Primary Outcome Measures:
  • Subject Rating of the Natural Look and Feel of the Lips [ Time Frame: 4 weeks ]
    Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.

  • Injector Rating of the Natural Look and Feel of the Lips [ Time Frame: 4 weeks ]
    Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.


Secondary Outcome Measures:
  • Bruising of the Lips [ Time Frame: 15 minutes after injection ]
    Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips

  • Swelling of the Lips [ Time Frame: 15 minutes after injection ]
    Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips

  • Ease of Injection [ Time Frame: 15 minutes after injection ]
    Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)

  • Malleability of Product [ Time Frame: 15 minutes after injection ]
    Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)

  • Need for Massage [ Time Frame: 15 minutes after injection ]
    Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA

  • Return to Social Engagement [ Time Frame: 4 weeks ]
    Time to return to normal daily activities

  • Comparative Rating With Previous Treatment [ Time Frame: 15 minutes after injection ]
    Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse

  • Rating of Injection Discomfort [ Time Frame: 15 minutes after injection ]
    The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).


Enrollment: 62
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Volbella
Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use
Device: Crosslinked hyaluronic acid gel
All treatments are carried out according to the physician's experience and the Directions for Use
Other Name: JUVÉDERM VOLBELLA™

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers desiring lip augmentation
Criteria

Inclusion Criteria:

  • Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
  • Females and males ≥ 18 years of age
  • Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results

Exclusion Criteria:

  • Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
  • Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  Contacts and Locations
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): NCT01629134


Locations
Germany
Dusseldorf, North Rhine-Westphalia, Germany
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Medical Monitor Allergan Medical
  More Information

Publications:
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01629134     History of Changes
Other Study ID Numbers: MAF/AGN/MED/FIL/019
First Submitted: June 25, 2012
First Posted: June 27, 2012
Results First Submitted: March 21, 2013
Results First Posted: May 14, 2013
Last Update Posted: October 13, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents