Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds - Full Text View

Purpose

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

Condition	Intervention	Phase
Nasolabial Folds	Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine Device: A gel of hyaluronic acid (concentration of 20 mg/mL)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator)

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Primary Outcome Measures:

Procedural Pain Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Comparative Pain [ Time Frame: 1 day ] [ Designated as safety issue: No ]
A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF

Enrollment:	32
Study Start Date:	November 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Juvederm Ultra Injectable Gel with Lidocaine	Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL Other Name: Juvederm® Ultra Injectable Gel with Lidocaine
Active Comparator: 2 Restylane Injectable Gel	Device: A gel of hyaluronic acid (concentration of 20 mg/mL) Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL Other Name: Restylane® Injectable Gel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850889

Locations

Canada, Ontario

Niagara Falls, Ontario, Canada

Sponsors and Collaborators

Allergan Medical

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00850889 History of Changes
Other Study ID Numbers:	MA-JULIDO-0801
Study First Received:	February 23, 2009
Results First Received:	February 24, 2011
Last Updated:	March 23, 2011
Health Authority:	Canada: IRB

Keywords provided by Allergan Medical:

Aesthetic correction of nasolabial folds

Additional relevant MeSH terms:

Hyaluronic Acid
Lidocaine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013