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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00850889
Other study ID # MA-JULIDO-0801
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2008
Est. completion date November 2008

Study information

Verified date December 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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
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