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Phase 4 Completed N=32 Randomized Single-blind Other

Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

Nasolabial Folds
Source: ClinicalTrials.gov NCT00850889 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Procedural Pain Score — 2.0; 4.1 units on a scale

Summary

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

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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