Phase 4
N=32
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT00850889 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Procedural Pain Score — 2.0; 4.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine (Device); A gel of hyaluronic acid (concentration of 20 mg/mL) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan Medical
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Pain Score |
2.0; 4.1 | — |
| SECONDARY Comparative Pain |
34; 50; 3; 9; 3 | — |
| SECONDARY Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity |
1.4; 1.3 | — |
| SECONDARY Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity |
1.5; 1.4 | — |
Summary
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00850889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.