A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
Unnamed facility
Chapel Hill, North Carolina, United States
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
Time frame: Baseline, Month 6
Participant Assessed Procedural and Post-Procedural Pain Levels
The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
Time frame: During injection, immediately following injection, 15, 30, and 45 min post-injection
Subject's Global Assessment of Change in Appearance of Perioral Lines
The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Time frame: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6
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