Evaluation of the sensitivity of the Merz Cheeks Fullness Assessment Scale (MCFAS) and the clinical relevance of aesthetically pleasing outcomes by detecting changes in cheek appearance after Belotero® Volume Lidocaine injection. The safety objectives include the identification and description of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), serious adverse device effects (SADEs), anticipated serious adverse device effects (ASADEs) and unanticipated adverse device effects (UADEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
Mode of application: subdermal injection
Institute of Cosmetic and Laser Surgery; Merz Inverstigational Site #0010409
Oakville, Ontario, Canada
Research Toronto; Merz Investigational Site #0010408
Toronto, Ontario, Canada
Cosmetic Dermatology Toronto Yorkville; Merz Investigational Site #'0010412
Toronto, Ontario, Canada
Comparison of the responder rate between the treatment group and the untreated control group at Week 4, according to the Merz Cheeks Fullness Assessment Scale (MCFAS) as assessed by a blinded evaluator.
Treatment response is defined as ≥ 1-point improvement on both cheeks compared to baseline. The MCFAS is a 5-point ordinal rating scale ranging from 0 (full cheek) to 5 (very severely sunken cheek).
Time frame: Week 4
Descriptive summary of the FACE-Q satisfaction of the midface for treated subjects at baseline and Week 4
Subject's assessment is based on the entire face. FACE-Q scores are derived from questionaires 'satisfaction with cheeks' (including 5 questions relating to the satisfaction with cheek appearance, answers range from 1 (very dissatisfied) to 4 (very satisfied)), and the module 'patient-perceived age visual analogue scale' (VAS - scale ranging from -15 (15 years younger) to 15 (15 years older)).
Time frame: Week 4
Average percent change of the FACE-Q satisfaction of the midface for treated subjects from baseline to Week 4
Subject's assessment is based on the entire face. FACE-Q scores are derived from questionaires 'satisfaction with cheeks' (including 5 questions relating to the satisfaction with cheek appearance, answers range from 1 (very dissatisfied) to 4 (very satisfied)), and the module 'patient-perceived age visual analogue scale' (VAS - scale ranging from -15 (15 years younger) to 15 (15 years older)).
Time frame: Week 4
Descriptive summary of Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 4, as completed by the treating investigator.
This assessment is a measure of aesthetic improvement relative to the baseline, pre-treatment condition, as assessed from photographs. The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved).
Time frame: Week 4
Descriptive summary of GAIS scores for treated subjects at Week 4, as completed by the subject.
This assessment is a measure of aesthetic improvement relative to the baseline, pre-treatment condition, as assessed from photographs. The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +3 (very much improved).
Time frame: Week 4
Evaluate the incidence and nature of device- and/or injection-related AEs, and SAEs observed during the study.
Time frame: Week 4
Common treatment site responses (CTRs) will be evaluated using subject diaries
Time frame: Week 4
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