Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

Lip Augmentation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629134
• Other study ID #: MAF/AGN/MED/FIL/019
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: October 3, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lip Augmentation

Intervention

Device:
• Crosslinked hyaluronic acid gel
All treatments are carried out according to the physician's experience and the Directions for Use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Bruising of the Lips	Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips	15 minutes after injection	Yes
Secondary	Swelling of the Lips	Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips	15 minutes after injection	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Return to Social Engagement	Time to return to normal daily activities	4 weeks	No
Secondary	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	No
Secondary	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	Yes