Status:
COMPLETED
Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
Lead Sponsor:
Allergan Medical
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00653861
Start Date
April 1 2008
End Date
July 1 2008
Last Update
October 13 2014
Active Locations (1)
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1
Mount Kisco, New York, United States