Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01629134
First received: June 25, 2012
Last updated: October 3, 2014
Last verified: October 2014
  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:

Primary Outcome Measures:
  • Subject Rating of the Natural Look and Feel of the Lips [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time to return to normal daily activities

  • Comparative Rating With Previous Treatment [ Time Frame: 15 minutes after injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT01629134     History of Changes
Other Study ID Numbers: MAF/AGN/MED/FIL/019
Study First Received: June 25, 2012
Results First Received: March 21, 2013
Last Updated: October 3, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 20, 2014