Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
Completed · Not applicable
Conditions studied: Nasolabial Folds
In brief
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
Key facts
- Study ID
- NCT00653861
- Run by
- Allergan Medical
- People needed
- 72
- Starts
- 2008-04-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2014-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Study site — Mount Kisco, New York, United States
Full record on ClinicalTrials.gov
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