NCT00850889

Brief Summary

Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

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

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 21, 2011

Completed
Last Updated

January 9, 2019

Status Verified

December 1, 2018

Enrollment Period

Same day

First QC Date

February 23, 2009

Results QC Date

February 24, 2011

Last Update Submit

December 19, 2018

Conditions

Nasolabial Folds

Keywords

Aesthetic correction of nasolabial folds

Outcome Measures

Primary Outcomes (1)

  • Procedural Pain Score

    Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.

    1 day

Secondary Outcomes (3)

  • Comparative Pain

    1 day

  • Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity

    Day 0, Day 14

  • Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity

    Day 0, Day 14

Study Arms (2)

1

ACTIVE COMPARATOR

Juvederm Ultra Injectable Gel with Lidocaine

Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine

2

ACTIVE COMPARATOR

Restylane Injectable Gel

Device: A gel of hyaluronic acid (concentration of 20 mg/mL)

Interventions

Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaineDEVICE

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Also known as: Juvederm® Ultra Injectable Gel with Lidocaine
1
A gel of hyaluronic acid (concentration of 20 mg/mL)DEVICE

Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Also known as: Restylane® Injectable Gel
2

Eligibility Criteria

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

You may qualify if:

  • Desires correction of moderate to severe nasolabial folds (NLFs)
  • Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
  • Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study

You may not qualify if:

  • Cosmetic facial procedures \[e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy\] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
  • Initiating use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the study
  • Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
  • Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
  • Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
  • Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
  • Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Niagara Falls, Ontario, Canada

Location

Related Publications (1)

  • Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9.

    PMID: 20936295BACKGROUND

Results Point of Contact

Title
Steven P. James, MD, VP, Global Medical Affairs
Organization
Allergan, Inc.
james_steven@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 25, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 9, 2019

Results First Posted

April 21, 2011

Record last verified: 2018-12

Locations

CA(1)