A randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
211
Injectable gel
Injectable gel
Galderma Research Site
Calgary, Alberta, Canada
Galderma Research Site
Edmonton, Alberta, Canada
Galderma Research Site
Edmonton, Alberta, Canada
Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies
Investigator's and Blinded Evaluator's live assessment on validated 4-grade photographic Medicis Midface Volume Scale (MMVS) to rate the subject's right and left midface separately for severity of volume deficiency. The change from baseline at Month 3 will be the response variable
Time frame: 3 Months
Effectiveness of GP0112 and comparator-control based on the validated 4-grade Medicis Midface Volume Scale (MMVS) assessment
Responder rate based on the Blinded Evaluator's live assessment of the validated 4-grade Medicis Midface Volume Scale (MMVS). A responder is defined as a subject with at least 1 grade improvement from baseline on both sides of the face concurrently
Time frame: 3, 6, 9, 12, 15, 18 and 19 Months
Effectiveness of GP0112 on the Global Aesthetic Improvement Scale (GAIS)
Percentage of responders, defined by having at least "Improved" (improved, much improved or very much improved) on the Global Aesthetic Improvement Scale (GAIS) by the subject and treating investigator
Time frame: 3, 6, 9, 12, 15, 18 and 19 Months
Effectiveness of GP0112 and comparator-control using the FACE-Q
Change from baseline in FACE-Q Satisfaction with Cheeks Rasch transformed total score, as well as proportion of subjects in each response category for each of the individual questions for the FACE-Q Satisfaction with Cheeks and Satisfaction with Outcome questionnaires
Time frame: 3, 6, 9, 12, 15, 18 and 19 Months
Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire (SSQ)
Proportion of subjects in each response category (strongly agree, agree, neutral, disagree or strongly disagree) for every question in the Subject Satisfaction Questionnaire (SSQ)
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Galderma Research Site
Vancouver, British Columbia, Canada
Galderma Research Site
Vancouver, British Columbia, Canada
Galderma Research Site
Vancouver, British Columbia, Canada
Galderma Research Site
Winnipeg, Manitoba, Canada
Galderma Research Site
Oakville, Ontario, Canada
Galderma Research Site
Richmond Hill, Ontario, Canada
Galderma Research Site
Toronto, Ontario, Canada
...and 5 more locations
Time frame: 3, 6, 9, 12, 15,18 and 19 Months
Effectiveness of GP0112 and comparator-control in returning to social engagement
Time in hours until the subject feels comfortable returning to social engagement after treatment, based on subject diary reporting
Time frame: 3, 6, 9, 12, 15,18 and 19 Months
Safety of GP0112 in cheek augmentation and correction of midface contour deficiencies adverse events (AEs)
Incidence, intensity, time to onset and duration of adverse events
Time frame: Up to 19 Months
Safety of GP0112 in cheek augmentation and correction of midface contour pre-defined expected post-treatment events
Incidence, intensity and number of days of pre-defined expected post-treatment events collected using subject diaries for 28 days following each treatment
Time frame: Up to 19 Months