A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes. This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.
Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).
Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Patient Satisfaction With Validated FACE-Q Aesthetics Survey
Absolute Change of the Patient Satisfaction using the validated FACE-Q Aesthetics questionnaire for patient reported assessment of treatment by domain. The absolute change from the patient reported outcome score prior to injection to the patient reported score immediate post-injection. Increase in numeric value indicates the larger patient reported improvement, except for psychosocial distress module where a decrease in numeric value indicates patient improvement. Maximum change 99 and Minimum Change 0.
Time frame: 2 week post injections
Correlate Patient Satisfaction With Volumetric Measurements
Linear correlation of relative volumetric change over relative patient satisfaction scale change. These values are reported as correlation coefficients and are unit less.
Time frame: upto 90 days
Volumetric Changes of Treatment
3-dimensional photography to measure volumetric changes in each treatment
Time frame: immediately post injection, 2 weeks, 4 weeks, and 12 weeks
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