Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips

NCT01629134 | Completed Results

• 1 other identifier: MAF/AGN/MED/FIL/019
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lip Augmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Bruising of the Lips

  15 minutes after injection

• Swelling of the Lips

  15 minutes after injection

• Ease of Injection

  15 minutes after injection

• Malleability of Product

  15 minutes after injection

• Need for Massage

  15 minutes after injection

Study Arms (1)

Volbella

Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use

Device: Crosslinked hyaluronic acid gel

Interventions

Crosslinked hyaluronic acid gel DEVICE

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

Also known as: JUVÉDERM VOLBELLA™

Volbella

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers desiring lip augmentation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (1)

Unknown Facility

Düsseldorf, North Rhine-Westphalia, Germany

Location

Related 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.

  PMID: 24910276 RESULT

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Monitor

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: May 14, 2013

Record last verified: 2014-10

Locations

DE (1)