NCT01579305

Brief Summary

The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 5, 2014

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

April 16, 2012

Results QC Date

June 27, 2014

Last Update Submit

January 9, 2019

Conditions

Lip Volume Enhancement

Outcome Measures

Primary Outcomes (1)

  • Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment

    The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).

    3 months

Study Arms (2)

Juvéderm® Volbella with Lidocaine

EXPERIMENTAL

Subjects injected with Juvéderm® Volbella with Lidocaine in their lips

Device: Juvéderm® Volbella with Lidocaine

Restylane-L®

ACTIVE COMPARATOR

Subjects injected with Restylane-L® in their lips

Device: Restylane-L®

Interventions

Juvéderm® Volbella with LidocaineDEVICE

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Juvéderm® Volbella with Lidocaine
Restylane-L®DEVICE

Up to 4.0 mL at the discretion of the Investigator to achieve optimal results

Restylane-L®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Desire enhancement of his/her vermilion borders and/or vermilion mucosa
  • Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)
  • Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

You may not qualify if:

  • Have undergone cosmetic facial, lip or perioral procedures \[e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
  • Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Cannes, France

Location

Unknown Facility

Glasgow, United Kingdom

Location

Related Publications (1)

  • Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.

    PMID: 25878932BACKGROUND

Results Point of Contact

Title
Medical Monitor
Organization
Allergan, Inc.
devicetrials@allergan.com
805 961 5000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 17, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2013

Study Completion

January 1, 2014

Last Updated

January 17, 2019

Results First Posted

August 5, 2014

Record last verified: 2019-01

Locations

FR(1)GB(1)