Clinical trial NCT00850889: Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Folds
Keywords: Aesthetic correction of nasolabial folds
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Procedural Pain Score
timeFrame: 1 day
Secondary outcomes:
measure: Comparative Pain
timeFrame: 1 day
measure: Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity
timeFrame: Day 0, Day 14
measure: Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity
timeFrame: Day 0, Day 14
Other outcomes:
Locations:
city: Niagara Falls
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9.