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.

Study Overview

• Status: Completed
• Conditions: Lip Augmentation
• Intervention / Treatment: Device: Crosslinked hyaluronic acid gel

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Dusseldorf, North Rhine-Westphalia, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers desiring lip augmentation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: JUVÉDERM VOLBELLA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Rating of the Natural Look and Feel of the Lips	Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.	4 weeks
Injector Rating of the Natural Look and Feel of the Lips	Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruising of the Lips	Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips	15 minutes after injection
Swelling of the Lips	Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips	15 minutes after injection
Ease of Injection	Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)	15 minutes after injection
Malleability of Product	Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)	15 minutes after injection
Need for Massage	Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA	15 minutes after injection
Return to Social Engagement	Time to return to normal daily activities	4 weeks
Comparative Rating With Previous Treatment	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	15 minutes after injection
Rating of Injection Discomfort	The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).	15 minutes after injection

Collaborators and Investigators

• Sponsor: Allergan Medical

Publications and helpful links

General Publications

• Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MAF/AGN/MED/FIL/019