A Study of the Lifting Capacity of Fillers

Study Overview
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Brief Summary
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Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity, viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested in animal models. To date, there are no studies that measure the lifting capacity of fillers in an in-vivo human model. The intention is to study the lifting capacity of fillers in a group of patients by comparing pre and post-procedure two and three-dimensional photographs using analytic software. Specifically, the PI is interested in determining the amount of tissue elevation created by injecting HAs Restylane-Lyft®, and Restylane-L® (Galderma Laboratories, L.P., Fort Worth, TX) to the midface and to the lower face, both in the anterior-posterior direction and in the vertical direction by using analytic software. The research group has identified a reliable and reproducible quantitative assessment of midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face deflates and descends, and, in the practice, is also a means of assessing the midface in youth and in aging. The PI's findings have been published in the Aesthetic Surgery Journal. The practice will also attempt to utilize this metric as a measure of midface aesthetic lifting capacity. The practice will also employ 3 D photography and analytic software to determine degree of lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post- injection. (Vectra, Canfield, Fairfield, NJ) We will recruit patients from a population of subjects that generally would receive fillers to improve changes associated with facial volume loss and divide them in to two groups based on chronologic age.

Detailed Description
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All fillers will be injected in locations where the FDA has approved it for on-label indications (the cheek, subcutaneously and supraperiosteally, the dermis and subdermis for the correction of wrinkles and folds such as the nasolabial fold) and placed as usual and customary using techniques as practiced by the authors and as are accepted widely. Additional steps prior to injection for this study are temporary sterile magic marker markings markers on the face and detailed photography, both 2D and 3D, that will be taken before, during, and after injection, and the segmentation of injections such that the midface will be injected prior to and separately from the lower face. Three dimensional data will be analyzed using Vectra analytic software, and 2-D photographs will be analyzed by measuring improvements in WIZDOM (width of the interzygomatic distance of the midface) and its distance to the inner canthus.

Official Title
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A Study of the Lifting Capacity of Fillers

Conditions
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Esthetic & Topographic Shifts From Facial Fillers

Intervention / Treatment
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* Device: injection of Restylane Lyft and Restylane L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 40-60 Midface, lower face volume loss and gravitational changes amenable to the administration of HA fillers. Filler requirements, based on experienced injector assessment, on the order of 8 syringes. Exclusion Criteria: History of prior filler injections in the past 12 months. Pregnancy/planned pregnancy Allergy to HA products

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women aged 40-50<br>Intervention--Injections of volumizing products Restylane L and Restylane Lyft with endpoint  a dramatic result is seen that is agreed upon by both subject and injector. The number of injections will be determined (and quantified) by both the patient and the PI to achieve this endpoint. | Device: injection of Restylane Lyft and Restylane L<br>* Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups<br>|
| Experimental: Women aged 50-60<br>Intervention--Injections of volumizing products Restylane L and Restylane Lyft with endpoint  a dramatic result is seen that is agreed upon by both subject and injector. The number of injections will be determined (and quantified) by both the patient and the PI to achieve this endpoint. | Device: injection of Restylane Lyft and Restylane L<br>* Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree and axes of volume shifts before and after injection of HA fillers | The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler. | immediately after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of MMVS | Medicis Midface Volume Scale | Two weeks post injections. | 
| Patient and Observer Satisfaction with Degree of Lift | Change in global aesthetic assessment measured from baseline. | immediately after injection | 
| Measure the capacity of fillers in the midface to change midface position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection | 
| Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek. | WIZDOM measurement and WIZDOM -IC measurement | immediately after injection | 
| Measure the capacity of fillers in the midface to change lower face position. | H1 and Vectra analytic software: movement of measured points of reference on the face. | immediately after injection | 
| Patient-reported subjective assessment of filler effect and satisfaction | GAIS Scale | Two weeks post injections. | 
| Investigator assessment of filler effect. | GAIS scale | Two weeks post injections. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WIZDOM, Facelift, HA Filler, Hyaluronic acid, Facial Rejuvenation, Aging Face, Midface lift, Midface augmentation