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OpenTrials
Completed

NCT Number: NCT01629134

Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.

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Key information

Conditions

Lip Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Düsseldorf, North Rhine-Westphalia, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crosslinked hyaluronic acid gel

Device

All treatments are carried out according to the physician's experience and the Directions for Use

Other names: JUVÉDERM VOLBELLA™

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. Return to Social Engagement

    Time frame: 4 weeks

    Time to return to normal daily activities

  7. 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

  8. 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).

Sponsors and collaborators

Lead sponsor

Allergan Medical

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2012
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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