A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects undergoing correction of nasolabial folds (NLFs)
This is a randomized, multicenter, double-blind, split-face study in subjects seeking nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of the face for each study product will be randomly assigned. The investigator and the subject will be blinded to the treatment; injections of the study product will be performed by an unblinded injecting investigator. At each visit, investigator and subject evaluations of the treated areas will be performed and recorded
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Comparator without lidocaine
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection
Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
Time frame: at injection Time 0
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.
Time frame: 15, 30, 45, and 60 minutes post injection and at 2 weeks post injection
Wrinkle Severity Rating Score (WSRS)
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Patient Global Aesthetic Improvement
Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.
Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
Investigator Global Aesthetic Improvement
Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.
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Time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)