NCT00653861

Brief Summary

Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable

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

April 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 30, 2009

Completed
Last Updated

October 13, 2014

Status Verified

December 1, 2013

Enrollment Period

2 months

First QC Date

April 2, 2008

Results QC Date

July 22, 2009

Last Update Submit

October 6, 2014

Conditions

Nasolabial Folds

Keywords

Aesthetic correction

Outcome Measures

Primary Outcomes (1)

  • Procedural Pain Score

    Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.

    1 day

Secondary Outcomes (2)

  • Comparative Pain

    1 day

  • Nasolabial Fold (NLF) Severity

    2 weeks

Study Arms (2)

Juvederm with Lidocaine

EXPERIMENTAL

Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold.

Device: JUVÉDERM™ Injectable Gel with Lidocaine

Juvederm

ACTIVE COMPARATOR

Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold.

Device: JUVÉDERM™ Injectable Gel

Interventions

JUVÉDERM™ Injectable Gel with LidocaineDEVICE

Single treatment, volume determined by investigator

Juvederm with Lidocaine
JUVÉDERM™ Injectable GelDEVICE

Single treatment, volume determined by investigator

Juvederm

Eligibility Criteria

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

You may qualify if:

  • Be male or female, 18 years of age or older
  • Desire correction of moderate to severe nasolabial folds (NLFs)
  • Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score

You may not qualify if:

  • Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
  • Begin 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 are planning to begin use of such products during the study.
  • Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
  • Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
  • Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
  • Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mount Kisco, New York, United States

Location

Related Publications (1)

  • Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.

    PMID: 19735519RESULT

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan Medical
devicetrials@allergan.com
(805) 961-5500

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, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

October 13, 2014

Results First Posted

December 30, 2009

Record last verified: 2013-12

Locations

US(1)