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

Nasolabial Folds Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850889
• Other study ID #: MA-JULIDO-0801
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
• A gel of hyaluronic acid (concentration of 20 mg/mL)
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Pain Score	Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.	1 day
Secondary	Comparative Pain	A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.	1 day
Secondary	Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity	Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF	Day 0, Day 14
Secondary	Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity	Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF	Day 0, Day 14