Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep. 1. to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit). 2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported 3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30. 4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported 5. to evaluate all adverse events during the course of the study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).
Arthur Swift Research Inc.
Montreal, Quebec, Canada
Subject-reported time of return to social engagement after initial treatment
Time of return to social engagement (in hours)
Time frame: 30 days
Change from baseline to post-treatment follow-up time points in subject reported GAIS
Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30
Time frame: up to 30 days
Subject satisfaction with treatment outcome of the nasolabial folds
Subject satisfaction with treatment assessments at baseline, day 14, and day 30
Time frame: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS
Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30
Time frame: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS
Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30
Time frame: 30 days
Incidence rate of subjects with adverse events (AEs)
Time frame: 30 days
Incidence rate of subjects with injection-related adverse events
Injection-related adverse events recorded by the subject in study diary
Time frame: 30 days
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